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FDA 510(k)

CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY

K-Number: K010953 · 2001-06-06

ApplicantAbbott Laboratories
Decision Date2001-06-06
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K010953. 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 CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY?

CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Abbott Laboratories. The 510(k) number is K010953.

When did CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY receive FDA 510(k) clearance?

CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY received FDA 510(k) clearance on 2001-06-06, under 510(k) number K010953.

Who is the listed applicant for CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY?

The FDA product code for CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY 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.

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