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FDA 510(k)

APO B RIA KIT

K-Number: K851389 · 1985-07-10

ApplicantIso-Tex Diagnostics
Decision Date1985-07-10
Product CodeMSJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

APO B RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Iso-Tex Diagnostics. It received FDA 510(k) clearance on 1985-07-10 under 510(k) number K851389. 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 RIA KIT?

APO B RIA KIT is a medical device that received FDA 510(k) clearance on 1985-07-10. The listed applicant is Iso-Tex Diagnostics. The 510(k) number is K851389.

When did APO B RIA KIT receive FDA 510(k) clearance?

APO B RIA KIT received FDA 510(k) clearance on 1985-07-10, under 510(k) number K851389.

Who is the listed applicant for APO B RIA KIT?

The FDA 510(k) record lists Iso-Tex Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APO B RIA KIT?

The FDA product code for APO B RIA KIT is MSJ.

Other records listing Iso-Tex Diagnostics 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.

K840105APO A-I RIA KIT-HUMAN PLASMA APOLIP-K782081RIA SYSTEM, PARATHYROID HORMONE

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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