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FDA 510(k)

RAICHEM GLUCOSE UV REAGENT

K-Number: K012668 · 2001-10-15

ApplicantHemagen Diagnostics, Inc.
Decision Date2001-10-15
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM GLUCOSE UV 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 2001-10-15 under 510(k) number K012668. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM GLUCOSE UV REAGENT?

RAICHEM GLUCOSE UV REAGENT is a medical device that received FDA 510(k) clearance on 2001-10-15. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K012668.

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

RAICHEM GLUCOSE UV REAGENT received FDA 510(k) clearance on 2001-10-15, under 510(k) number K012668.

Who is the listed applicant for RAICHEM GLUCOSE UV 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 GLUCOSE UV REAGENT?

The FDA product code for RAICHEM GLUCOSE UV REAGENT is CFR.

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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.

K041052RAICHEM GLUCOSE UV (LIQUID)K041051RAICHEM BUN RATE REAGENT (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: CFR)

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.

K253490Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsRoche DiagnosticsK252357Glucose2Abbott IrelandK220134cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK191899Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutionsRoche DiagnosticsK170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK153644ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL IIElitechgroup

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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