CK Reagent

FDA 510(k) K971396 · Carolina Liquid Chemistries Corp.

Substantially Equivalent

510(k) numberK971396

Submission

Device name
CK Reagent
Applicant
Carolina Liquid Chemistries Corp.
Brea, CA, US
Received
April 15, 1997
Decision date
May 29, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

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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K971324Triglycerides, TG, or TrigCDT · Traditional 06/20/1997SE
K971967BunCDQ · Traditional 06/17/1997SE
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Questions and answers

When was CK Reagent cleared by the FDA?

CK Reagent (K971396) received a 510(k) decision of Substantially Equivalent on May 29, 1997, 44 days after the submission was received.

What is the product code of K971396?

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.