SERAYZER ALT/SGPT REAGENT STRIPS
FDA 510(k) clearance K832791 · decided 1983-10-14
Clearance details
- K-number
- K832791
- Device name
- SERAYZER ALT/SGPT REAGENT STRIPS
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-19
- Decision date
- 1983-10-14
- Days to decision
- 56 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 |
|---|---|---|
| SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (K780507) | Gamma Enterprises, Inc. | 1978-05-03 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |