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FDA 510(k)

HDL PRECIPITATING REAGENT

K-Number: K893966 · 1989-07-25

ApplicantDiagnostic Systems
Decision Date1989-07-25
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL PRECIPITATING REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K893966. 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 HDL PRECIPITATING REAGENT?

HDL PRECIPITATING REAGENT is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Diagnostic Systems. The 510(k) number is K893966.

When did HDL PRECIPITATING REAGENT receive FDA 510(k) clearance?

HDL PRECIPITATING REAGENT received FDA 510(k) clearance on 1989-07-25, under 510(k) number K893966.

Who is the listed applicant for HDL PRECIPITATING REAGENT?

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

What is the FDA product code for HDL PRECIPITATING REAGENT?

The FDA product code for HDL PRECIPITATING REAGENT is LBR.

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Other records listing Diagnostic Systems 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.

K905146OLYMPUS URINE PHK893691EMDS CREATINE KINASE ITEM NIMBER 65411K893692EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405K884993VISUAL BLOOD GLUCOSE TEST SYSTEMK881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641K880787EASY-TEST LACTIC ACID (LA)

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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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