FDA Product Code
FDA Product Code KSX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.9160
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | Gamma Biologicals, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | Gamma Biologicals, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K800916 | P1 BLOOD GROUP SUBSTANCE | Travenol Laboratories, S.A. | 1980-05-08 | Traditional | PDF ↗ |
| K781896 | BLOOD GROUP SUBSTANCE A,B | North American Biologicals, Inc. | 1978-12-20 | Traditional | PDF ↗ |
| K781862 | BLOOD GROUP SUBSTANCE A | North American Biologicals, Inc. | 1978-12-20 | Traditional | PDF ↗ |
| K781895 | BLOOD GROUP SUBSTANCE B | North American Biologicals, Inc. | 1978-12-20 | Traditional | PDF ↗ |
| K771488 | P1 BLOOD GROUP SUBSTANCE | Ortho Diagnostics, Inc. | 1977-11-08 | Traditional | PDF ↗ |
| K771487 | LEWIS BLOOD GROUP SUBSTANCE | Ortho Diagnostics, Inc. | 1977-11-08 | Traditional | PDF ↗ |
Product code KSX · Class II · Hematology. Data: openFDA.