FDA 510(k)

ANTI-LEU-12 B CELL REAGENT

K-Number: K851639 · 1986-07-02

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1986-07-02

Product CodeLJD

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ANTI-LEU-12 B CELL REAGENT 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 1986-07-02 under 510(k) number K851639. The device is classified under product code LJD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-LEU-12 B CELL REAGENT?

ANTI-LEU-12 B CELL REAGENT is a medical device that received FDA 510(k) clearance on 1986-07-02. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K851639.

When did ANTI-LEU-12 B CELL REAGENT receive FDA 510(k) clearance?

ANTI-LEU-12 B CELL REAGENT received FDA 510(k) clearance on 1986-07-02, under 510(k) number K851639.

Who is the listed applicant for ANTI-LEU-12 B CELL REAGENT?

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 ANTI-LEU-12 B CELL REAGENT?

The FDA product code for ANTI-LEU-12 B CELL REAGENT is LJD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.