Panels › Hematology › Product code KSX · Class 2
Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
Regulation 864.9160
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KSX
| Company | 510(k)s | Recalls |
|---|---|---|
| North American Biologicals, Inc. | 3 | 0 |
| Gamma Biologicals, Inc. | 2 | 0 |
| Ortho Diagnostics, Inc. | 2 | 0 |
| Travenol Laboratories, S.A. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 12, 1980 | K802534 | GAMMA PI BLOOD GROUP SUBSTANCE Gamma Biologicals, Inc. | KSX |
| Nov 12, 1980 | K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE Gamma Biologicals, Inc. | KSX |
| May 8, 1980 | K800916 | P1 BLOOD GROUP SUBSTANCE Travenol Laboratories, S.A. | KSX |
| Dec 20, 1978 | K781896 | BLOOD GROUP SUBSTANCE A,B North American Biologicals, Inc. | KSX |
| Dec 20, 1978 | K781895 | BLOOD GROUP SUBSTANCE B North American Biologicals, Inc. | KSX |
| Dec 20, 1978 | K781862 | BLOOD GROUP SUBSTANCE A North American Biologicals, Inc. | KSX |
| Nov 8, 1977 | K771488 | P1 BLOOD GROUP SUBSTANCE Ortho Diagnostics, Inc. | KSX |
| Nov 8, 1977 | K771487 | LEWIS BLOOD GROUP SUBSTANCE Ortho Diagnostics, Inc. | KSX |
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