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FDA 510(k)

AFFINITY(TM) HTSH IMMUNIT(TM)

K-Number: K865081 · 1987-03-12

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1987-03-12
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AFFINITY(TM) HTSH IMMUNIT(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1987-03-12 under 510(k) number K865081. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFINITY(TM) HTSH IMMUNIT(TM)?

AFFINITY(TM) HTSH IMMUNIT(TM) is a medical device that received FDA 510(k) clearance on 1987-03-12. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K865081.

When did AFFINITY(TM) HTSH IMMUNIT(TM) receive FDA 510(k) clearance?

AFFINITY(TM) HTSH IMMUNIT(TM) received FDA 510(k) clearance on 1987-03-12, under 510(k) number K865081.

Who is the listed applicant for AFFINITY(TM) HTSH IMMUNIT(TM)?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFINITY(TM) HTSH IMMUNIT(TM)?

The FDA product code for AFFINITY(TM) HTSH IMMUNIT(TM) is JLW.

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Related Devices (Code: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, 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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