Hichem Ck/Nac Reagent Kit

FDA 510(k) K962247 · Elan Pharma, Inc.

Substantially Equivalent

510(k) numberK962247

Submission

Device name
Hichem Ck/Nac Reagent Kit
Applicant
Elan Pharma, Inc.
Brea, CA, US
Received
June 11, 1996
Decision date
August 15, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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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More from Arkray, Inc.

510(k)DeviceDecision
K982469Hichem Cholesterol Reagent KitCHH · Traditional 08/19/1998SE
K981769Hichem Phosphorus Reagent KitCEO · Traditional 06/29/1998SE
K960115Hichem Bun/Urea Reagent KitCDQ · Traditional 03/29/1996SE

Questions and answers

When was Hichem Ck/Nac Reagent Kit cleared by the FDA?

Hichem Ck/Nac Reagent Kit (K962247) received a 510(k) decision of Substantially Equivalent on August 15, 1996, 65 days after the submission was received.

What is the product code of K962247?

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.