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FDA 510(k)

APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC

K-Number: K864393 · 1987-01-16

ApplicantIntl. Diagnostic Laboratories, Ltd.
Decision Date1987-01-16
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Laboratories, Ltd.. It received FDA 510(k) clearance on 1987-01-16 under 510(k) number K864393. 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 A1 (APO A1) IMMUNOTURBIDIMETRIC?

APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC is a medical device that received FDA 510(k) clearance on 1987-01-16. The listed applicant is Intl. Diagnostic Laboratories, Ltd.. The 510(k) number is K864393.

When did APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC receive FDA 510(k) clearance?

APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC received FDA 510(k) clearance on 1987-01-16, under 510(k) number K864393.

Who is the listed applicant for APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC?

The FDA 510(k) record lists Intl. Diagnostic Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC?

The FDA product code for APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC is MSJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Intl. Diagnostic Laboratories, Ltd. 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.

K864811ROTA-STATK864228APO B., IMMUNOTURBIDIMETRIC ASSAYK843367ROTAVIRUS ENZYME IMMUNOASSAY

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

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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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