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FDA 510(k)

FLOW-PAC LDH REAGENT SET

K-Number: K823721 · 1983-01-09

ApplicantAmresco, Inc.
Decision Date1983-01-09
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLOW-PAC LDH REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1983-01-09 under 510(k) number K823721. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOW-PAC LDH REAGENT SET?

FLOW-PAC LDH REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-01-09. The listed applicant is Amresco, Inc.. The 510(k) number is K823721.

When did FLOW-PAC LDH REAGENT SET receive FDA 510(k) clearance?

FLOW-PAC LDH REAGENT SET received FDA 510(k) clearance on 1983-01-09, under 510(k) number K823721.

Who is the listed applicant for FLOW-PAC LDH REAGENT SET?

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

What is the FDA product code for FLOW-PAC LDH REAGENT SET?

The FDA product code for FLOW-PAC LDH REAGENT SET is CFJ.

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Other records listing Amresco, 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.

K905618GGT REAGENTK904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176K905684ALKALINE PHOSPHATASEK905544MAGNESIUM REAGENTK905284HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173K904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116

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Related Devices (Code: CFJ)

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.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

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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