Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CPK-CS

K-Number: K790357 · 1979-04-04

ApplicantHoffmann-La Roche, Inc.
Decision Date1979-04-04
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CPK-CS is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1979-04-04 under 510(k) number K790357. The device is classified under product code JHT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPK-CS?

CPK-CS is a medical device that received FDA 510(k) clearance on 1979-04-04. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K790357.

When did CPK-CS receive FDA 510(k) clearance?

CPK-CS received FDA 510(k) clearance on 1979-04-04, under 510(k) number K790357.

Who is the listed applicant for CPK-CS?

The FDA 510(k) record lists Hoffmann-La Roche, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPK-CS?

The FDA product code for CPK-CS is JHT.

Other records listing Hoffmann-La Roche, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K850727BHCG-ROCHE EIAK831694RENAKK830462ABUSCREEN RADIOUMMUNOASSAY--URINEK830480ABUSCREEN RADIOIMMUNOASSAY-COCAINE METAK830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEK830461ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE

View all 49 devices →

Related Devices (Code: JHT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTSpectral Diagnostics, Inc.K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIPrinceton BioMeditech Corp.K930359CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305Helena LaboratoriesK904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, Inc.K904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc.K901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBIntl. Immunoassay Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑