510(k) K032027
- Device
- CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
- Applicant
- CHOLESTECH CORP.
- 510(k) number
- K032027
- Product code
- CIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-05
- Date received
- 2003-07-01
- Regulation
- 862.1100
- Classification name
- Hydrazone Colorimetry, Ast/sgot
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS E WORTHY
- Address
- 3347 Investment Blvd. Hayward CA US 94545 94545
FDA Registration Numbers#
- 3010891909
- 3004493545
Source Documents#
Other 510(k) Records For Product Code CIS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K896238 | COBAS READY AST REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 |
| K854187 | IN-VITRO TEST DETERMINATION OF SGOT (AST) | Clinical Data, Inc. | 1985-11-25 |
| K812872 | OPTIONAL TOTAL CA-MODULE FOR IL 504/508 | Instrumentation Laboratory CO | 1981-10-26 |
| K792410 | ELVI SGOT & SGPT TRANSAMINASE | Volu Sol Medical Industries | 1979-12-06 |
Legacy Summary#
summary
FDA Review#
Decision Summary