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FDA 510(k)

AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711

K-Number: K900667 · 1990-04-19

ApplicantAmerican Research Products Co.
Decision Date1990-04-19
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 is the device name listed in this FDA 510(k) record. The listed applicant is American Research Products Co.. It received FDA 510(k) clearance on 1990-04-19 under 510(k) number K900667. 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 AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711?

AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 is a medical device that received FDA 510(k) clearance on 1990-04-19. The listed applicant is American Research Products Co.. The 510(k) number is K900667.

When did AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 receive FDA 510(k) clearance?

AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 received FDA 510(k) clearance on 1990-04-19, under 510(k) number K900667.

Who is the listed applicant for AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711?

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

What is the FDA product code for AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711?

The FDA product code for AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 is CFJ.

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Other records listing American Research Products Co. 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.

K942984BUN REAGENTK901527BIURET (COLORMETRIC), TOTAL PROTEINK901960IRON REAGENTS PRODUCT CODES 7725 AND 7726K901964PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463K900827COLORIMETRIC CHLORIDE PRODUCT #4314125K901702NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522

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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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