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FDA 510(k)

SIMULTEST(TM) IMK-LYMPHOCYTE

K-Number: K913192 · 1992-02-06

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1992-02-06
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIMULTEST(TM) IMK-LYMPHOCYTE 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 1992-02-06 under 510(k) number K913192. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMULTEST(TM) IMK-LYMPHOCYTE?

SIMULTEST(TM) IMK-LYMPHOCYTE is a medical device that received FDA 510(k) clearance on 1992-02-06. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K913192.

When did SIMULTEST(TM) IMK-LYMPHOCYTE receive FDA 510(k) clearance?

SIMULTEST(TM) IMK-LYMPHOCYTE received FDA 510(k) clearance on 1992-02-06, under 510(k) number K913192.

Who is the listed applicant for SIMULTEST(TM) IMK-LYMPHOCYTE?

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 SIMULTEST(TM) IMK-LYMPHOCYTE?

The FDA product code for SIMULTEST(TM) IMK-LYMPHOCYTE is GKZ.

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Related Devices (Code: GKZ)

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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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