OPTIONAL TOTAL CA-MODULE FOR IL 504/508
FDA 510(k) clearance K812872 · decided 1981-10-26
Clearance details
- K-number
- K812872
- Device name
- OPTIONAL TOTAL CA-MODULE FOR IL 504/508
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 1981-10-14
- Decision date
- 1981-10-26
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- CIS
- Device class
- 2
- Regulation number
- 862.1100
- 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 |
|---|---|---|
| CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (K032027) | Cholestech Corp. | 2003-09-05 |
| COBAS READY AST REAGENT (K896238) | Roche Diagnostic Systems, Inc. | 1990-02-16 |
| IN-VITRO TEST DETERMINATION OF SGOT (AST) (K854187) | Clinical Data, Inc. | 1985-11-25 |
| ELVI SGOT & SGPT TRANSAMINASE (K792410) | Volu Sol Medical Industries | 1979-12-06 |
Recalls involving this device
No recalls on record reference this clearance.