510(k) K896238
- Device
- Cobas Ready Ast Reagent
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K896238
- Product code
- CIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-16
- Date received
- 1989-10-30
- Regulation
- 862.1100
- Classification name
- Hydrazone Colorimetry, Ast/Sgot
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALEX WESOLOWSKI
- Address
- One Sunset Ave. Montclair NJ US 07042 07042
FDA Registration Numbers#
- 3010891909
- 3004493545
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CIS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | Cholestech Corp. | 2003-09-05 |
| 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 |