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FDA 510(k)

ROCHE REAGENT FOR APOLIPOPROTEIN B

K-Number: K910552 · 1991-05-07

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1991-05-07
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE REAGENT FOR APOLIPOPROTEIN B 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 1991-05-07 under 510(k) number K910552. The device is classified under product code MSJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE REAGENT FOR APOLIPOPROTEIN B?

ROCHE REAGENT FOR APOLIPOPROTEIN B is a medical device that received FDA 510(k) clearance on 1991-05-07. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K910552.

When did ROCHE REAGENT FOR APOLIPOPROTEIN B receive FDA 510(k) clearance?

ROCHE REAGENT FOR APOLIPOPROTEIN B received FDA 510(k) clearance on 1991-05-07, under 510(k) number K910552.

Who is the listed applicant for ROCHE REAGENT FOR APOLIPOPROTEIN B?

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 REAGENT FOR APOLIPOPROTEIN B?

The FDA product code for ROCHE REAGENT FOR APOLIPOPROTEIN B is MSJ.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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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: MSJ)

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.

K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYGeneral AtomicsK073488DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXDiazyme LaboratoriesK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORSPointe Scientific, Inc.,K063608DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGHDade Behring, Inc.K9926628 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEMBayer Corp.K970314SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTSBeckman Instruments, 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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