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FDA 510(k)

RAICHEM LIPID CALIBRATOR

K-Number: K022767 · 2002-09-03

ApplicantHemagen Diagnostics, Inc.
Decision Date2002-09-03
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM LIPID CALIBRATOR 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 2002-09-03 under 510(k) number K022767. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM LIPID CALIBRATOR?

RAICHEM LIPID CALIBRATOR is a medical device that received FDA 510(k) clearance on 2002-09-03. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K022767.

When did RAICHEM LIPID CALIBRATOR receive FDA 510(k) clearance?

RAICHEM LIPID CALIBRATOR received FDA 510(k) clearance on 2002-09-03, under 510(k) number K022767.

Who is the listed applicant for RAICHEM LIPID CALIBRATOR?

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 LIPID CALIBRATOR?

The FDA product code for RAICHEM LIPID CALIBRATOR is JIX.

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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: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

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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