SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
FDA 510(k) clearance K780507 · decided 1978-05-03
Clearance details
- K-number
- K780507
- Device name
- SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
- Applicant
- Gamma Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-30
- Decision date
- 1978-05-03
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- CKC
- Device class
- 1
- Regulation number
- 862.1030
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| SERAYZER ALT/SGPT REAGENT STRIPS (K832791) | Miles Laboratories, Inc. | 1983-10-14 |
Recalls involving this device
No recalls on record reference this clearance.