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FDA 510(k)

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

K-Number: K012287 · 2001-08-07

ApplicantRoche Diagnostics Corp.
Decision Date2001-08-07
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: COBAS INTEGRA LDL-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 2001-08-07 under 510(k) number K012287. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION is a medical device that received FDA 510(k) clearance on 2001-08-07. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K012287.

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

MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION received FDA 510(k) clearance on 2001-08-07, under 510(k) number K012287.

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

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

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Related Devices (Code: MRR)

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.

K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.K210801AXINON® LDL-p Test SystemNumares AGK161691Direct LDL Cholesterol (LDL)Randox Laboratories LimitedK091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022Alfa Wassermann, Inc.K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMedica Corp.K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLiposcience

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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