GAMMA LEWIS BLOOD GROUP SUBSTANCE
FDA 510(k) clearance K802533 · decided 1980-11-12
Clearance details
- K-number
- K802533
- Device name
- GAMMA LEWIS BLOOD GROUP SUBSTANCE
- Applicant
- Gamma Biologicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-15
- Decision date
- 1980-11-12
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- KSX
- Device class
- 2
- Regulation number
- 864.9160
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.