FDA 510(k)

8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM

K-Number: K992662 · 2000-02-15

Decision Date2000-02-15

Product CodeMSJ

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 2000-02-15 under 510(k) number K992662. 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 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM?

8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-15. The listed applicant is Bayer Corp.. The 510(k) number is K992662.

When did 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM receive FDA 510(k) clearance?

8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM received FDA 510(k) clearance on 2000-02-15, under 510(k) number K992662.

Who is the listed applicant for 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM?

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

What is the FDA product code for 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM?

The FDA product code for 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM is MSJ.

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Other records listing Bayer Corp. as applicant

K024062ASCENSIA BREEZE BLOOD GLUCOSE METER K023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST K024017BAYER ADVIA CENTAUR HER-2/NEU ASSAY K024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM K023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

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Related Devices (Code: MSJ)

K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYGeneral Atomics K073488DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXXDiazyme Laboratories K061377APOLIPOPROTEIN 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.K970314SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTSBeckman Instruments, Inc.K964010IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENTBeckman 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.