FDA 510(k)

LDH ISOENZYME REAGENT

K-Number: K791657 · 1979-09-17

ApplicantElectrophoresis Corp. of America

Decision Date1979-09-17

Product CodeCFE

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

LDH ISOENZYME REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Electrophoresis Corp. of America. It received FDA 510(k) clearance on 1979-09-17 under 510(k) number K791657. The device is classified under product code CFE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDH ISOENZYME REAGENT?

LDH ISOENZYME REAGENT is a medical device that received FDA 510(k) clearance on 1979-09-17. The listed applicant is Electrophoresis Corp. of America. The 510(k) number is K791657.

When did LDH ISOENZYME REAGENT receive FDA 510(k) clearance?

LDH ISOENZYME REAGENT received FDA 510(k) clearance on 1979-09-17, under 510(k) number K791657.

Who is the listed applicant for LDH ISOENZYME REAGENT?

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

What is the FDA product code for LDH ISOENZYME REAGENT?

The FDA product code for LDH ISOENZYME REAGENT is CFE.

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Other records listing Electrophoresis Corp. of America as applicant

K802396GENERAL PROCEDURE AGAROSE FILM K792548ALKALINE PHOSPHATASE MARKER K792553AGAROSE BARBITAL-EDTA BUFFER K792551ALKALINE PHOSPHATASE REAGENT K792547AGAROSE BARBITAL BUFFER K792574MOPSO BUFFER

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Related Devices (Code: CFE)

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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.