CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
FDA 510(k) clearance K032027 · decided 2003-09-05
Clearance details
- K-number
- K032027
- Device name
- CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
- Applicant
- Cholestech Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-01
- Decision date
- 2003-09-05
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- CIS
- Device class
- 2
- Regulation number
- 862.1100
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hayward, CA, 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 |
|---|---|---|
| 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 |
| 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
| Record | Firm | Date |
|---|---|---|
| Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative d recall (Z-1139-2013) | Alere San Diego, Inc. | 2013-04-17 |