Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30
FDA 510(k) K974003 · Diagnostic Chemicals , Ltd.
510(k) numberK974003
Submission
- Device name
- Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E.I., CA - Received
- October 21, 1997
- Decision date
- December 5, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
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Questions and answers
When was Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30 cleared by the FDA?
Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30 (K974003) received a 510(k) decision of Substantially Equivalent on December 5, 1997, 45 days after the submission was received.
What is the product code of K974003?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.