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FDA 510(k)

MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION

K-Number: K012286 · 2001-08-08

ApplicantRoche Diagnostics Corp.
Decision Date2001-08-08
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2001-08-08 under 510(k) number K012286. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION?

MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION is a medical device that received FDA 510(k) clearance on 2001-08-08. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K012286.

When did MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION receive FDA 510(k) clearance?

MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION received FDA 510(k) clearance on 2001-08-08, under 510(k) number K012286.

Who is the listed applicant for MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION?

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

What is the FDA product code for MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION?

The FDA product code for MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION is LBS.

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Related Devices (Code: LBS)

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.

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation

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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