Cpk-Cs

FDA 510(k) K790357 · Hoffmann-La Roche, Inc.

Substantially Equivalent

510(k) numberK790357

Submission

Device name
Cpk-Cs
Applicant
Hoffmann-La Roche, Inc.
Mchenry, IL, US
Received
February 23, 1979
Decision date
April 4, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JHT – Chromatographic Separation, Cpk Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Specialty
Clinical Chemistry

Other 510(k)s with product code JHT

510(k)DeviceApplicantDecision
K022409Spectral's Cardiac Status Ck-Mb Rapid TestJHT · Traditional Spectral Diagnostics, Inc.09/30/2002SE
K991299Modification to Cardiac Status Ck-Mb/Myoglobin Rapid One-Step Test, Lifesign Mi…JHT · Traditional Princeton BioMeditech Corp.05/28/1999SE
K930359Cardio Rep-Cat. No. 1400 & CK Isoforms Kit 3305JHT · Traditional Helena Laboratories04/12/1993SE
K904866Coulter Ck-Mb Isoenzyme ReagentJHT · Traditional Coulter Electronics, Inc.12/13/1990SE
K904721DSL Ck-Mb (DSL #3200)JHT · Traditional Diagnostic Systems Laboratories, Inc.12/13/1990SE
K901450Modified Label for Embria-Ck, Quick-Mb/Micromi-MbJHT · Traditional Intl. Immunoassay Laboratories, Inc.05/15/1990SE
K896170Rep CK Isoforms Kit Cat. No. 3081, 3082, 3083JHT · Traditional Helena Laboratories02/16/1990SE
K881168Creatine Kinase (CK) Isoenzyme MBJHT · Traditional Data Medical Associates, Inc.11/10/1988SE
K874284Shot-Gun Isolat Proced/Measurement Ck-Mb in SerumJHT · Traditional Diagnostic Chemicals, Ltd. (Usa)01/21/1988SE
K872041Coulter Dart Ck-Mb Isoenzyme Reagent SystemJHT · Traditional Coulter Electronics, Inc.09/16/1987SE

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K830462Abuscreen Radioummunoassay--UrineDOE · Traditional 03/24/1983SE
K830461Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional 03/24/1983SE
K830460Abuscreen Radioimmunoassay for MorphineDOE · Traditional 03/24/1983SE
K830479Abuscreen Radioimmunoassay-BarbiturateDKN · Traditional 03/10/1983SE
K823580Cobas Reagent for Inorganic PhosphorusCEO · Traditional 01/07/1983SE

Questions and answers

When was Cpk-Cs cleared by the FDA?

Cpk-Cs (K790357) received a 510(k) decision of Substantially Equivalent on April 4, 1979, 40 days after the submission was received.

What is the product code of K790357?

The FDA product code is JHT – Chromatographic Separation, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.