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FDA 510(k)

RAICHEM PHOSPORUS REAGENT

K-Number: K003012 · 2000-10-25

ApplicantHemagen Diagnostics, Inc.
Decision Date2000-10-25
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM PHOSPORUS REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 2000-10-25 under 510(k) number K003012. 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 PHOSPORUS REAGENT?

RAICHEM PHOSPORUS REAGENT is a medical device that received FDA 510(k) clearance on 2000-10-25. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K003012.

When did RAICHEM PHOSPORUS REAGENT receive FDA 510(k) clearance?

RAICHEM PHOSPORUS REAGENT received FDA 510(k) clearance on 2000-10-25, under 510(k) number K003012.

Who is the listed applicant for RAICHEM PHOSPORUS REAGENT?

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

What is the FDA product code for RAICHEM PHOSPORUS REAGENT?

The FDA product code for RAICHEM PHOSPORUS REAGENT is CEO.

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Other records listing Hemagen Diagnostics, 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.

K041051RAICHEM BUN RATE REAGENT (LIQUID)K041052RAICHEM GLUCOSE UV (LIQUID)K041009RAICHEM CALCIUM (OCPC) LIQUID REAGENTK031101RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2K023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERK022772RAICHEM LDL-CHOLESTEROL DIRECT 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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