Rep E-Z CK-30 Isoenzyme Kit
FDA 510(k) K925801 · Helena Laboratories
510(k) numberK925801
Submission
- Device name
- Rep E-Z CK-30 Isoenzyme Kit
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- November 16, 1992
- Decision date
- December 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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Questions and answers
When was Rep E-Z CK-30 Isoenzyme Kit cleared by the FDA?
Rep E-Z CK-30 Isoenzyme Kit (K925801) received a 510(k) decision of Substantially Equivalent on December 28, 1992, 42 days after the submission was received.
What is the product code of K925801?
The FDA product code is CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.