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FDA 510(k)

APOLIPOPROTEIN TEST SYSTEM

K-Number: K921037 · 1992-05-22

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-05-22
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APOLIPOPROTEIN TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-05-22 under 510(k) number K921037. 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 APOLIPOPROTEIN TEST SYSTEM?

APOLIPOPROTEIN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1992-05-22. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K921037.

When did APOLIPOPROTEIN TEST SYSTEM receive FDA 510(k) clearance?

APOLIPOPROTEIN TEST SYSTEM received FDA 510(k) clearance on 1992-05-22, under 510(k) number K921037.

Who is the listed applicant for APOLIPOPROTEIN TEST SYSTEM?

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

What is the FDA product code for APOLIPOPROTEIN TEST SYSTEM?

The FDA product code for APOLIPOPROTEIN TEST SYSTEM is MSJ.

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Other records listing Baxter Diagnostics, 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.

K934458DRIED GRAM-POSITIVE MIC/COMBO PANELSK950817DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCIK935704DRIED GRAM-NEGATIVE MIC//COMBO PANELSK950570STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAYK945235DRIED GRAM-POSITIVE MIC/COMBO PANELSK941030DRIED GRAM-NEGATIVE CEFPODOXIME

View all 72 devices →

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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