Cobas Ready Ast Reagent
FDA 510(k) K896238 · Roche Diagnostic Systems, Inc.
510(k) numberK896238
Submission
- Device name
- Cobas Ready Ast Reagent
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- October 30, 1989
- Decision date
- February 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIS – Hydrazone Colorimetry, Ast/Sgot
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1100
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032027 | Cholestech LDX Aspartate Aminotransferase (Ast)CIS · Traditional | Cholestech Corp. | 09/05/2003SE |
| K854187 | In-Vitro Test Determination of Sgot (Ast)CIS · Traditional | Clinical Data, Inc. | 11/25/1985SE |
| K812872 | Optional Total Ca-Module for Il 504/508CIS · Traditional | Instrumentation Laboratory CO | 10/26/1981SE |
| K792410 | Elvi Sgot & SGPT TransaminaseCIS · Traditional | Volu Sol Medical Industries | 12/06/1979SE |
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Questions and answers
When was Cobas Ready Ast Reagent cleared by the FDA?
Cobas Ready Ast Reagent (K896238) received a 510(k) decision of Substantially Equivalent on February 16, 1990, 109 days after the submission was received.
What is the product code of K896238?
The FDA product code is CIS – Hydrazone Colorimetry, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.