FDA 510(k)

SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE

K-Number: K904209 · 1990-12-11

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1990-12-11

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE 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 1990-12-11 under 510(k) number K904209. 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 T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE?

SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE is a medical device that received FDA 510(k) clearance on 1990-12-11. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K904209.

When did SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE receive FDA 510(k) clearance?

SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE received FDA 510(k) clearance on 1990-12-11, under 510(k) number K904209.

Who is the listed applicant for SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE?

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 T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE?

The FDA product code for SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE is 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.