KSX
8 FDA 510(k) clearances · Product code
44 daysmedian time to decision
95 days90th percentile
8clearances measured
FDA profile
- Official device name
- Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.9160
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GAMMA LEWIS BLOOD GROUP SUBSTANCE (K802533) | Gamma Biologicals, Inc. | 1980-11-12 |
| GAMMA PI BLOOD GROUP SUBSTANCE (K802534) | Gamma Biologicals, Inc. | 1980-11-12 |
| P1 BLOOD GROUP SUBSTANCE (K800916) | Travenol Laboratories, S.A. | 1980-05-08 |
| BLOOD GROUP SUBSTANCE A (K781862) | North American Biologicals, Inc. | 1978-12-20 |
| BLOOD GROUP SUBSTANCE B (K781895) | North American Biologicals, Inc. | 1978-12-20 |
| BLOOD GROUP SUBSTANCE A,B (K781896) | North American Biologicals, Inc. | 1978-12-20 |
| LEWIS BLOOD GROUP SUBSTANCE (K771487) | Ortho Diagnostics, Inc. | 1977-11-08 |
| P1 BLOOD GROUP SUBSTANCE (K771488) | Ortho Diagnostics, Inc. | 1977-11-08 |
Track KSX automatically
Every clearance here is in the API, with alerts when new ones post.