Elvi Sgot & SGPT Transaminase
FDA 510(k) K792410 · Volu Sol Medical Industries
510(k) numberK792410
Submission
- Device name
- Elvi Sgot & SGPT Transaminase
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- November 26, 1979
- Decision date
- December 6, 1979
- 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 |
| K896238 | Cobas Ready Ast ReagentCIS · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| 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 |
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| K822128 | Volu-Sol Single Differential StainICN · Traditional | 08/05/1982SE |
| K822127 | Volu-Sol Zenkers FixativeIFH · Traditional | 08/05/1982SE |
| K822126 | Volu-Sol Carnoy FluidIGM · Traditional | 08/05/1982SE |
| K822038 | Volu-Sol Orange G-6(GILLS-MODHZH · Traditional | 08/03/1982SE |
| K822037 | Volu-Sol Tap Water SubstitutePPM · Traditional | 08/03/1982SE |
| K822036 | Volu-Sol DecalciferKDX · Traditional | 08/03/1982SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | 08/03/1982SE |
| K812906 | Elvi Biclot 816KQG · Traditional | 07/22/1982SE |
| K821541 | Hematoxylin IIIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Elvi Sgot & SGPT Transaminase cleared by the FDA?
Elvi Sgot & SGPT Transaminase (K792410) received a 510(k) decision of Substantially Equivalent on December 6, 1979, 10 days after the submission was received.
What is the product code of K792410?
The FDA product code is CIS – Hydrazone Colorimetry, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.