510(k) K812872
- Device
- Optional Total Ca-module For Il 504/508
- Applicant
- INSTRUMENTATION LABORATORY CO.
- 510(k) number
- K812872
- Product code
- CIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-10-26
- Date received
- 1981-10-14
- 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 |
| K792410 | ELVI SGOT & SGPT TRANSAMINASE | Volu Sol Medical Industries | 1979-12-06 |