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FDA 510(k)

ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)

K-Number: K973369 · 1997-11-21

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1997-11-21
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K973369. 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 ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)?

ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K973369.

When did ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) receive FDA 510(k) clearance?

ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973369.

Who is the listed applicant for ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)?

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

What is the FDA product code for ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)?

The FDA product code for ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) is LBR.

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Other records listing Roche Diagnostic Systems, 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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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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