IN-VITRO TEST DETERMINATION OF SGOT (AST)
FDA 510(k) clearance K854187 · decided 1985-11-25
Clearance details
- K-number
- K854187
- Device name
- IN-VITRO TEST DETERMINATION OF SGOT (AST)
- Applicant
- Clinical Data, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-15
- Decision date
- 1985-11-25
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- CIS
- Device class
- 2
- Regulation number
- 862.1100
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Clinical Data
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| OPTIONAL TOTAL CA-MODULE FOR IL 504/508 (K812872) | Instrumentation Laboratory CO | 1981-10-26 |
| ELVI SGOT & SGPT TRANSAMINASE (K792410) | Volu Sol Medical Industries | 1979-12-06 |
Recalls involving this device
No recalls on record reference this clearance.