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FDA 510(k)

REFLOTRON HDL CHOLESTEROL TEST TABS

K-Number: K902568 · 1990-08-09

ApplicantBoehringer Mannheim Corp.
Decision Date1990-08-09
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFLOTRON HDL CHOLESTEROL TEST TABS is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1990-08-09 under 510(k) number K902568. 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 REFLOTRON HDL CHOLESTEROL TEST TABS?

REFLOTRON HDL CHOLESTEROL TEST TABS is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K902568.

When did REFLOTRON HDL CHOLESTEROL TEST TABS receive FDA 510(k) clearance?

REFLOTRON HDL CHOLESTEROL TEST TABS received FDA 510(k) clearance on 1990-08-09, under 510(k) number K902568.

Who is the listed applicant for REFLOTRON HDL CHOLESTEROL TEST TABS?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFLOTRON HDL CHOLESTEROL TEST TABS?

The FDA product code for REFLOTRON HDL CHOLESTEROL TEST TABS is LBR.

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Other records listing Boehringer Mannheim Corp. 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.

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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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