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FDA 510(k)

CPK ISOENZYME SUBSTRATE

K-Number: K790309 · 1979-04-04

ApplicantElectrophoresis Corp.
Decision Date1979-04-04
Product CodeJHY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CPK ISOENZYME SUBSTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Electrophoresis Corp.. It received FDA 510(k) clearance on 1979-04-04 under 510(k) number K790309. The device is classified under product code JHY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPK ISOENZYME SUBSTRATE?

CPK ISOENZYME SUBSTRATE is a medical device that received FDA 510(k) clearance on 1979-04-04. The listed applicant is Electrophoresis Corp.. The 510(k) number is K790309.

When did CPK ISOENZYME SUBSTRATE receive FDA 510(k) clearance?

CPK ISOENZYME SUBSTRATE received FDA 510(k) clearance on 1979-04-04, under 510(k) number K790309.

Who is the listed applicant for CPK ISOENZYME SUBSTRATE?

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

What is the FDA product code for CPK ISOENZYME SUBSTRATE?

The FDA product code for CPK ISOENZYME SUBSTRATE is JHY.

Related Clinical Trials

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.

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Other records listing Electrophoresis Corp. 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.

K802395SPECIAL PROCEDURE AQAROSE FILMK790310HEMOGLOBIN CONTROLSK790311LDH ISOENZYME REAGENT

Related Devices (Code: JHY)

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.

K132571ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAYRoche DiagnosticsK070835OLYMPUS CK-MB REAGENTOlympus Life & Material Science Europa GmbH (IrishK022757SPIFE CK KIT, MODEL 3332, 3333Helena LaboratoriesK022654MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MBRoche Diagnostics Corp.K974421ELECSYS CK-MB STATBoehringer Mannheim Corp.K970343MMB METHODDade Chemistry Systems, 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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