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FDA 510(k)

AFFINITY HLH TEST SYSTEM

K-Number: K903407 · 1990-09-07

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1990-09-07
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AFFINITY HLH TEST 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 1990-09-07 under 510(k) number K903407. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFINITY HLH TEST SYSTEM?

AFFINITY HLH TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1990-09-07. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K903407.

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

AFFINITY HLH TEST SYSTEM received FDA 510(k) clearance on 1990-09-07, under 510(k) number K903407.

Who is the listed applicant for AFFINITY HLH TEST 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 HLH TEST SYSTEM?

The FDA product code for AFFINITY HLH TEST SYSTEM is JJY.

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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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