510(k) K792410
- Device
- ELVI SGOT & SGPT TRANSAMINASE
- Applicant
- VOLU SOL MEDICAL INDUSTRIES
- 510(k) number
- K792410
- Product code
- CIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-12-06
- Date received
- 1979-11-26
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| 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 |
Legacy Summary#
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FDA Review#
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