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FDA 510(k)

DIAZYME APOLIPOPROTEIN A-1 ASSAY

K-Number: K072977 · 2008-07-16

ApplicantGeneral Atomics
Decision Date2008-07-16
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME APOLIPOPROTEIN A-1 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is General Atomics. It received FDA 510(k) clearance on 2008-07-16 under 510(k) number K072977. 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 DIAZYME APOLIPOPROTEIN A-1 ASSAY?

DIAZYME APOLIPOPROTEIN A-1 ASSAY is a medical device that received FDA 510(k) clearance on 2008-07-16. The listed applicant is General Atomics. The 510(k) number is K072977.

When did DIAZYME APOLIPOPROTEIN A-1 ASSAY receive FDA 510(k) clearance?

DIAZYME APOLIPOPROTEIN A-1 ASSAY received FDA 510(k) clearance on 2008-07-16, under 510(k) number K072977.

Who is the listed applicant for DIAZYME APOLIPOPROTEIN A-1 ASSAY?

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

What is the FDA product code for DIAZYME APOLIPOPROTEIN A-1 ASSAY?

The FDA product code for DIAZYME APOLIPOPROTEIN A-1 ASSAY is MSJ.

Related Clinical Trials

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Other records listing General Atomics 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.

K082488DIAZYME LP(A) ASSAYK072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSK050178HBA1C ENZYMATIC ASSAYK042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KITK033360DIAZYME LITHIUM ENZYMATIC ASSAY KIT

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.

K073488DIAZYME 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.K964010IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENTBeckman Instruments, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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