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CPK Reagent Set

by Medical Analysis Systems, Inc.

510(k) K780070

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780070 Date13 Feb 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CGS
Device Class
Class II
Regulation
21 CFR Part 862.1215
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CPK Reagent Set is a clinical chemistry device used for the measurement of creatine phosphokinase (CPK) or its isoenzymes through NAD reduction/NADH oxidation. This device is classified under the Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes category and is intended for in vitro diagnostic use in clinical laboratory settings.

The CPK Reagent Set is supplied as a reagent set and is classified as a Class 2 medical device. It is authorized under FDA 510(k) clearance K780070 with a Traditional clearance type, received on January 16, 1978, and determined to be Substantially Equivalent on February 13, 1978. The device is regulated under number 862.1215 and is manufactured by Medical Analysis Systems, Inc.

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