FDA 510(k)

MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION

K-Number: K980858 · 1998-05-22

ApplicantBecton Dickinson Immunocytometry Systems

Decision Date1998-05-22

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Immunocytometry Systems. It received FDA 510(k) clearance on 1998-05-22 under 510(k) number K980858. 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 MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION?

MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION is a medical device that received FDA 510(k) clearance on 1998-05-22. The listed applicant is Becton Dickinson Immunocytometry Systems. The 510(k) number is K980858.

When did MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION receive FDA 510(k) clearance?

MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION received FDA 510(k) clearance on 1998-05-22, under 510(k) number K980858.

Who is the listed applicant for MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION?

The FDA 510(k) record lists Becton Dickinson Immunocytometry Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION?

The FDA product code for MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION is GKZ.

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Other records listing Becton Dickinson Immunocytometry Systems as applicant

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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.