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FDA 510(k)

RAICHEM LDL-CHOLESTEROL DIRECT REAGENT

K-Number: K022772 · 2002-09-17

ApplicantHemagen Diagnostics, Inc.
Decision Date2002-09-17
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM LDL-CHOLESTEROL DIRECT 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 2002-09-17 under 510(k) number K022772. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM LDL-CHOLESTEROL DIRECT REAGENT?

RAICHEM LDL-CHOLESTEROL DIRECT REAGENT is a medical device that received FDA 510(k) clearance on 2002-09-17. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K022772.

When did RAICHEM LDL-CHOLESTEROL DIRECT REAGENT receive FDA 510(k) clearance?

RAICHEM LDL-CHOLESTEROL DIRECT REAGENT received FDA 510(k) clearance on 2002-09-17, under 510(k) number K022772.

Who is the listed applicant for RAICHEM LDL-CHOLESTEROL DIRECT 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 LDL-CHOLESTEROL DIRECT REAGENT?

The FDA product code for RAICHEM LDL-CHOLESTEROL DIRECT REAGENT is MRR.

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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 ANAYLZERK022767RAICHEM LIPID CALIBRATOR

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Related Devices (Code: MRR)

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.

K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.K210801AXINON® LDL-p Test SystemNumares AGK161691Direct LDL Cholesterol (LDL)Randox Laboratories LimitedK091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022Alfa Wassermann, Inc.K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMedica Corp.K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLiposcience

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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