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FDA 510(k)

AFFINITY(TM) SYSTEM

K-Number: K865105 · 1987-03-12

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

Device Summary

AFFINITY(TM) SYSTEM 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 K865105. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFINITY(TM) SYSTEM?

AFFINITY(TM) SYSTEM 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 K865105.

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

AFFINITY(TM) SYSTEM received FDA 510(k) clearance on 1987-03-12, under 510(k) number K865105.

Who is the listed applicant for AFFINITY(TM) SYSTEM?

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) SYSTEM?

The FDA product code for AFFINITY(TM) SYSTEM is JJE.

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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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