Antisera, Immunoperoxidase, Chlamydia Spp.
Microbiology · 21 CFR 866.3120
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
6 recall events for this product code
- Encore Medical, LpTerminatedAug 7, 2007
Femoral Speed Block Size 2, Part/Catalog #800-01-365; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; d
Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
Z-1135-2007 · View FDA record ↗ - Encore Medical, LpTerminatedAug 7, 2007
Femoral Speed Block Size 4 Part/Catalog #800-01-366; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; di
Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
Z-1136-2007 · View FDA record ↗ - Encore Medical, LpTerminatedAug 7, 2007
Femoral Speed Block Size 6, Part/Catalog #800-01-367; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; d
Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
Z-1137-2007 · View FDA record ↗ - Encore Medical, LpTerminatedAug 7, 2007
Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; d
Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
Z-1138-2007 · View FDA record ↗ - Encore Medical, LpTerminatedAug 7, 2007
Femoral Speed Block Size 10, Part/Catalog #800-01-369; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit;
Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
Z-1139-2007 · View FDA record ↗ - Encore Medical, LpTerminatedAug 7, 2007
Femoral Speed Block Size 12, Part/Catalog #800-01-370; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit;
Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
Z-1140-2007 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
8 clearances for this product code
- Savyon Diagnostics , Ltd.Mar 19, 1991
K910644 · IPAZYME (TM) CHLAMYDIA IGG-IGA
- Savyon Diagnostics , Ltd.Mar 8, 1991
K901975 · IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)
- Icn ImmunobiologicalsAug 15, 1989
K882674 · IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT
- Difco Laboratories, Inc.Jun 23, 1989
K893669 · CELLMATICS SHLAMYDIA DETECTION SYSTEM
- Scott Laboratories, Inc.Sep 19, 1985
K852869 · SELECTICULT-CHLAMYDIA
- Bartels Immunodiagnostic Supplies, Inc.Jul 20, 1984
K842151 · CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT
- Nicholas H. MaganiasMar 31, 1983
K830688 · COMBION SKIN TEST
- Immulok, Inc.Apr 14, 1982
K820390 · HISTOSET IMMUNOPEROXIDASE TISSURE KIT