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FDA 510(k)

CPK CLINI GEL KIT

K-Number: K791826 · 1979-10-01

ApplicantClinical Sciences, Inc.
Decision Date1979-10-01
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CPK CLINI GEL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1979-10-01 under 510(k) number K791826. 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 CLINI GEL KIT?

CPK CLINI GEL KIT is a medical device that received FDA 510(k) clearance on 1979-10-01. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K791826.

When did CPK CLINI GEL KIT receive FDA 510(k) clearance?

CPK CLINI GEL KIT received FDA 510(k) clearance on 1979-10-01, under 510(k) number K791826.

Who is the listed applicant for CPK CLINI GEL KIT?

The FDA 510(k) record lists Clinical Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPK CLINI GEL KIT?

The FDA product code for CPK CLINI GEL KIT is JHT.

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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.

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