FDA Product Code
FDA Product Code KSF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.9650
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K811713 | AVI-D CONTROL | Ortho Diagnostic Systems, Inc. | 1981-10-23 | Traditional | PDF ↗ |
| K810599 | DADE RH CONTROL REAGENT | American Dade | 1981-03-31 | Traditional | PDF ↗ |
| K801425 | RH CONTROL | North American Biologicals, Inc. | 1980-07-14 | Traditional | PDF ↗ |
| K800658 | RST-SERIES CONTROL | Gamma Biologicals, Inc. | 1980-04-16 | Traditional | PDF ↗ |
| K800310 | ORTHO ANTISERA CONTROL | Ortho Diagnostics, Inc. | 1980-03-05 | Traditional | PDF ↗ |
| K800239 | RH-HR NEGATIVE CONTROL REAGENT | Gotham Biologics, Inc. | 1980-02-21 | Traditional | PDF ↗ |
| K790249 | TEST CELLS | Hyland Therapeutic Div., Travenol Laboratories | 1979-05-16 | Traditional | PDF ↗ |
| K790025 | COUNTER CHECK, H001, H002, H003 | Diagnostic Technology, Inc. | 1979-01-17 | Traditional | PDF ↗ |
| K780665 | RECAP | Bca Biological Corp. of America | 1978-06-06 | Traditional | PDF ↗ |
| K780097 | QUALITY CONTROL SYSTEM, SPECTRA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-04-24 | Traditional | PDF ↗ |
| K771814 | REAGENT CONFIDENCE SERA | Ortho Diagnostics, Inc. | 1977-11-07 | Traditional | PDF ↗ |
| K761284 | UNIVAL CONTROL CELLS | Dade, Baxter Travenol Diagnostics, Inc. | 1977-01-25 | Traditional | PDF ↗ |
Product code KSF · Class II · Hematology. Data: openFDA.