Lactane Dehydrogenase-Sl Assay, Catalogue Number 327-10, 327-30
FDA 510(k) K974859 · Diagnostic Chemicals , Ltd.
510(k) numberK974859
Submission
- Device name
- Lactane Dehydrogenase-Sl Assay, Catalogue Number 327-10, 327-30
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E.I., CA - Received
- December 29, 1997
- Decision date
- January 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1440
- Specialty
- Clinical Chemistry
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Questions and answers
When was Lactane Dehydrogenase-Sl Assay, Catalogue Number 327-10, 327-30 cleared by the FDA?
Lactane Dehydrogenase-Sl Assay, Catalogue Number 327-10, 327-30 (K974859) received a 510(k) decision of Substantially Equivalent on January 22, 1998, 24 days after the submission was received.
What is the product code of K974859?
The FDA product code is CFJ – Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 862.1440.