GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
FDA 510(k) clearance K813342 · decided 1982-03-04
Clearance details
- K-number
- K813342
- Device name
- GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
- Applicant
- Gamma Biologicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-25
- Decision date
- 1982-03-04
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- KSK
- Device class
- 2
- Regulation number
- 864.9400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, 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 |
|---|---|---|
| FREEZE DRIED FICIN (K813404) | Biological Corp. of America | 1982-02-10 |
| FREEZE DRIED PAPAIN (K810803) | Biological Corp. of America | 1981-07-21 |
| AUTOMATED ENZYME (K780962) | Hyland Therapeutic Div., Travenol Laboratories | 1978-07-27 |
| AUTOZYME (K760123) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.