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FDA 510(k)

CPK - ISOENZYMES

K-Number: K760028 · 1976-09-15

ApplicantHarleco
Decision Date1976-09-15
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CPK - ISOENZYMES is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1976-09-15 under 510(k) number K760028. 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 - ISOENZYMES?

CPK - ISOENZYMES is a medical device that received FDA 510(k) clearance on 1976-09-15. The listed applicant is Harleco. The 510(k) number is K760028.

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

CPK - ISOENZYMES received FDA 510(k) clearance on 1976-09-15, under 510(k) number K760028.

Who is the listed applicant for CPK - ISOENZYMES?

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

What is the FDA product code for CPK - ISOENZYMES?

The FDA product code for CPK - ISOENZYMES is JHT.

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Other records listing Harleco as applicant

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Related Devices (Code: JHT)

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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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