Optional Total Ca-Module for Il 504/508
FDA 510(k) K812872 · Instrumentation Laboratory CO
510(k) numberK812872
Submission
- Device name
- Optional Total Ca-Module for Il 504/508
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- October 14, 1981
- Decision date
- October 26, 1981
- 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
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|---|---|---|---|
| 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 |
| K792410 | Elvi Sgot & SGPT TransaminaseCIS · Traditional | Volu Sol Medical Industries | 12/06/1979SE |
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Questions and answers
When was Optional Total Ca-Module for Il 504/508 cleared by the FDA?
Optional Total Ca-Module for Il 504/508 (K812872) received a 510(k) decision of Substantially Equivalent on October 26, 1981, 12 days after the submission was received.
What is the product code of K812872?
The FDA product code is CIS – Hydrazone Colorimetry, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.