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FDA 510(k)

APO B., IMMUNOTURBIDIMETRIC ASSAY

K-Number: K864228 · 1987-03-12

ApplicantIntl. Diagnostic Laboratories, Ltd.
Decision Date1987-03-12
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APO B., IMMUNOTURBIDIMETRIC ASSAY 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 1987-03-12 under 510(k) number K864228. 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 APO B., IMMUNOTURBIDIMETRIC ASSAY?

APO B., IMMUNOTURBIDIMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1987-03-12. The listed applicant is Intl. Diagnostic Laboratories, Ltd.. The 510(k) number is K864228.

When did APO B., IMMUNOTURBIDIMETRIC ASSAY receive FDA 510(k) clearance?

APO B., IMMUNOTURBIDIMETRIC ASSAY received FDA 510(k) clearance on 1987-03-12, under 510(k) number K864228.

Who is the listed applicant for APO B., IMMUNOTURBIDIMETRIC ASSAY?

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 APO B., IMMUNOTURBIDIMETRIC ASSAY?

The FDA product code for APO B., IMMUNOTURBIDIMETRIC ASSAY is MSJ.

Related Clinical Trials

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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-STATK864393APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRICK843367ROTAVIRUS 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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