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FDA 510(k)

AFFINITY(TM) I UPTAKE IMMUNIT(TM)

K-Number: K865083 · 1987-07-09

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1987-07-09
Product CodeKHQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AFFINITY(TM) I UPTAKE 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 1987-07-09 under 510(k) number K865083. The device is classified under product code KHQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFINITY(TM) I UPTAKE IMMUNIT(TM)?

AFFINITY(TM) I UPTAKE IMMUNIT(TM) is a medical device that received FDA 510(k) clearance on 1987-07-09. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K865083.

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

AFFINITY(TM) I UPTAKE IMMUNIT(TM) received FDA 510(k) clearance on 1987-07-09, under 510(k) number K865083.

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

The FDA product code for AFFINITY(TM) I UPTAKE IMMUNIT(TM) is KHQ.

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Related Devices (Code: KHQ)

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.

K981375ACE T UPTAKE REAGENT TU CALIBRATORSSchiapparelli Biosystems, Inc.K980088T-UPTAKE MICROPLATE EIAMonobindK970539CHIRON DIAGNOSTICS ACS:180TU PChiron Diagnostics Corp.K964308VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)Johnson & Johnson Clinical Diagnostics, Inc.K961488ELECSYS T-UPTAKE ASSAYBoehringer Mannheim Corp.K954807CEDIA T UPTAKE ASSAYBoehringer Mannheim Corp.

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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