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FDA 510(k)

COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT

K-Number: K982848 · 1998-10-01

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1998-10-01
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT 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 1998-10-01 under 510(k) number K982848. 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 COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT?

COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT is a medical device that received FDA 510(k) clearance on 1998-10-01. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K982848.

When did COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT receive FDA 510(k) clearance?

COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT received FDA 510(k) clearance on 1998-10-01, under 510(k) number K982848.

Who is the listed applicant for COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT?

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 COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT?

The FDA product code for COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT is MRR.

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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: 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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