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FDA 510(k)

RAICHEM HDL-CHOLESTEROL REAGENT

K-Number: K830207 · 1983-03-21

ApplicantReagents Applications, Inc.
Decision Date1983-03-21
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAICHEM HDL-CHOLESTEROL REAGENT 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 1983-03-21 under 510(k) number K830207. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAICHEM HDL-CHOLESTEROL REAGENT?

RAICHEM HDL-CHOLESTEROL REAGENT is a medical device that received FDA 510(k) clearance on 1983-03-21. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K830207.

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

RAICHEM HDL-CHOLESTEROL REAGENT received FDA 510(k) clearance on 1983-03-21, under 510(k) number K830207.

Who is the listed applicant for RAICHEM HDL-CHOLESTEROL REAGENT?

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 HDL-CHOLESTEROL REAGENT?

The FDA product code for RAICHEM HDL-CHOLESTEROL REAGENT is LBR.

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Other records listing Reagents Applications, Inc. as applicant

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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: LBR)

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.

K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral AtomicsK050823DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTeco DiagnosticsK023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERHemagen Diagnostics, Inc.K012593VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.K992029ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan DiagnosticsK992002AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, 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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