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FDA 510(k)

RAICHEM LDH-P REAGENT W/SEPARATE START-

K-Number: K831419 · 1983-06-16

ApplicantReagents Applications, Inc.
Decision Date1983-06-16
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM LDH-P REAGENT W/SEPARATE START- is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1983-06-16 under 510(k) number K831419. 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 RAICHEM LDH-P REAGENT W/SEPARATE START-?

RAICHEM LDH-P REAGENT W/SEPARATE START- is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K831419.

When did RAICHEM LDH-P REAGENT W/SEPARATE START- receive FDA 510(k) clearance?

RAICHEM LDH-P REAGENT W/SEPARATE START- received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831419.

Who is the listed applicant for RAICHEM LDH-P REAGENT W/SEPARATE START-?

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

What is the FDA product code for RAICHEM LDH-P REAGENT W/SEPARATE START-?

The FDA product code for RAICHEM LDH-P REAGENT W/SEPARATE START- is CFJ.

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Other records listing Reagents Applications, Inc. as applicant

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K982056RAICHEM CO2 REAGENTK972853CHOLESTEROL RAPID LIQUID REAGENTK922904RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND IIK915191RAI-TROL ELEVATED LIPIDS CONTROLK913398RAICHEM(TM) CREATINE KINASE-MB REAGENTK911900RAICHEM SPIA C3 REAGENT

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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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