KSXClass II
Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use
Hematology · 21 CFR 864.9160
MDR events0All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances8All time
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
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Gamma Biologicals, Inc.Nov 12, 1980
K802533 · GAMMA LEWIS BLOOD GROUP SUBSTANCE
- Gamma Biologicals, Inc.Nov 12, 1980
K802534 · GAMMA PI BLOOD GROUP SUBSTANCE
- Travenol Laboratories, S.A.May 8, 1980
K800916 · P1 BLOOD GROUP SUBSTANCE
- North American Biologicals, Inc.Dec 20, 1978
K781862 · BLOOD GROUP SUBSTANCE A
- North American Biologicals, Inc.Dec 20, 1978
K781895 · BLOOD GROUP SUBSTANCE B
- North American Biologicals, Inc.Dec 20, 1978
K781896 · BLOOD GROUP SUBSTANCE A,B
- Ortho Diagnostics, Inc.Nov 8, 1977
K771487 · LEWIS BLOOD GROUP SUBSTANCE
- Ortho Diagnostics, Inc.Nov 8, 1977
K771488 · P1 BLOOD GROUP SUBSTANCE