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FDA 510(k)

OPTIMIZED UV-LDH REAGENT SET

K-Number: K822492 · 1982-09-17

ApplicantBiorent Diagnostic, Inc.
Decision Date1982-09-17
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPTIMIZED UV-LDH REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Biorent Diagnostic, Inc.. It received FDA 510(k) clearance on 1982-09-17 under 510(k) number K822492. 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 OPTIMIZED UV-LDH REAGENT SET?

OPTIMIZED UV-LDH REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Biorent Diagnostic, Inc.. The 510(k) number is K822492.

When did OPTIMIZED UV-LDH REAGENT SET receive FDA 510(k) clearance?

OPTIMIZED UV-LDH REAGENT SET received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822492.

Who is the listed applicant for OPTIMIZED UV-LDH REAGENT SET?

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

What is the FDA product code for OPTIMIZED UV-LDH REAGENT SET?

The FDA product code for OPTIMIZED UV-LDH REAGENT SET is CFJ.

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Other records listing Biorent Diagnostic, 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.

K832747ALBUMIN REAGENT SETK823211CK-UV REAGENTK823060HEMOGLOBIN REAGENTK822494OPTIMIZED UV-GPT REAGENT SETK822493OPTIMIZED UV-GOT REAGENT SETK820768COLORIMETRIC LDH REAGENT SET

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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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