AUTOMATED ENZYME
FDA 510(k) clearance K780962 · decided 1978-07-27
Clearance details
- K-number
- K780962
- Device name
- AUTOMATED ENZYME
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1978-06-12
- Decision date
- 1978-07-27
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- KSK
- Device class
- 2
- Regulation number
- 864.9400
- 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 CHLOROQUINE DIPHOSPHATE SOLUTION (K813342) | Gamma Biologicals, Inc. | 1982-03-04 |
| FREEZE DRIED FICIN (K813404) | Biological Corp. of America | 1982-02-10 |
| FREEZE DRIED PAPAIN (K810803) | Biological Corp. of America | 1981-07-21 |
| AUTOZYME (K760123) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.