Panels › Hematology › Product code KSF · Class 2
Kit, Quality Control For Blood Banking Reagents
Regulation 864.9650
0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KSF
| Company | 510(k)s | Recalls |
|---|---|---|
| Ortho Diagnostics, Inc. | 2 | 0 |
| American Dade | 1 | 0 |
| Bca Biological Corp. of America | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Dade, Baxter Travenol Diagnostics, Inc. | 1 | 0 |
| Diagnostic Technology, Inc. | 1 | 0 |
| Gamma Biologicals, Inc. | 1 | 0 |
| Gotham Biologics, Inc. | 1 | 0 |
| Hyland Therapeutic Div., Travenol Laboratories | 1 | 0 |
| North American Biologicals, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 1981 | K811713 | AVI-D CONTROL Ortho Diagnostic Systems, Inc. | KSF |
| Mar 31, 1981 | K810599 | DADE RH CONTROL REAGENT American Dade | KSF |
| Jul 14, 1980 | K801425 | RH CONTROL North American Biologicals, Inc. | KSF |
| Apr 16, 1980 | K800658 | RST-SERIES CONTROL Gamma Biologicals, Inc. | KSF |
| Mar 5, 1980 | K800310 | ORTHO ANTISERA CONTROL Ortho Diagnostics, Inc. | KSF |
| Feb 21, 1980 | K800239 | RH-HR NEGATIVE CONTROL REAGENT Gotham Biologics, Inc. | KSF |
| May 16, 1979 | K790249 | TEST CELLS Hyland Therapeutic Div., Travenol Laboratories | KSF |
| Jan 17, 1979 | K790025 | COUNTER CHECK, H001, H002, H003 Diagnostic Technology, Inc. | KSF |
| Jun 6, 1978 | K780665 | RECAP Bca Biological Corp. of America | KSF |
| Apr 24, 1978 | K780097 | QUALITY CONTROL SYSTEM, SPECTRA Bd Becton Dickinson Vacutainer Systems Preanalytic | KSF |
| Nov 7, 1977 | K771814 | REAGENT CONFIDENCE SERA Ortho Diagnostics, Inc. | KSF |
| Jan 25, 1977 | K761284 | UNIVAL CONTROL CELLS Dade, Baxter Travenol Diagnostics, Inc. | KSF |
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