Olive Oil Emulsion (turbidimetric), Lipase
Clinical Chemistry · 21 CFR 862.1465
Recent MDR events
4 adverse event reports on file
- VBT SCREW, UNKNOWN SIZEDec 16, 2022InjuryZimmer Biomet Spine Inc.3012447612-2022-00308
- 300MM VBT CORDDec 16, 2022InjuryZimmer Biomet Spine Inc.3012447612-2022-00307
- VBT SCREW, UNKNOWN SIZEDec 16, 2022InjuryZimmer Biomet Spine Inc.3012447612-2022-00310
- VBT SCREW, UNKNOWN SIZEDec 16, 2022InjuryZimmer Biomet Spine Inc.3012447612-2022-00309
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
11 firms currently registered for this product code
Wiener Laboratorios S.a.i.c.
ROSARIO Santa Fe, AR
Teco Diagnostics
ANAHEIM, CA, US
Diamond Diagnostics Inc.
Budapest, HU
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Sanzay Corporation -
Miami Gardens, FL, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Bialex Lab
Wichita Falls, TX, US
Zhejiang Orient Gene Biotech
Huzhou Zhejiang, CN
510(k) clearances
15 clearances for this product code
- Teco DiagnosticsMar 6, 1997
K970124 · LIPASE REAGENT SET (COLIPASE METHOD)
- Medical Diagnostic Technologies, Inc.Jun 2, 1994
K940457 · LIPASE REAGENT SYSTEM
- Tech Intl. Co.Feb 18, 1992
K915706 · LIPASE REAGENT SET
- E.I. Dupont DE Nemours & Co., Inc.Jun 12, 1990
K901858 · MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST
- Electro-Nucleonics, Inc.Sep 28, 1989
K893718 · DELTATEST (R) LIPASE II
- Medical Analysis Systems, Inc.Mar 13, 1989
K885078 · LIPASE SR LIQUID STABLE REAGENT SET
- Beckman Instruments, Inc.Mar 12, 1987
K864438 · BECKMAN EPSILON(TM) LIPASE TEST KIT
- American DadeAug 4, 1986
K862440 · PARAMAX LIPASE REAGENT