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FDA 510(k)

RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT

K-Number: K870776 · 1987-03-13

ApplicantReagents Applications, Inc.
Decision Date1987-03-13
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT 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 1987-03-13 under 510(k) number K870776. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT?

RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K870776.

When did RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT receive FDA 510(k) clearance?

RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT received FDA 510(k) clearance on 1987-03-13, under 510(k) number K870776.

Who is the listed applicant for RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT?

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(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT?

The FDA product code for RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT is CEO.

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Other records listing Reagents Applications, 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.

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: CEO)

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.

K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic

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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