FDA 510(k)

ABBOTT CELL-DYN 4000 SYSTEM

K-Number: K961439 · 1996-10-18

Decision Date1996-10-18

Product CodeGKZ

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

ABBOTT CELL-DYN 4000 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics. It received FDA 510(k) clearance on 1996-10-18 under 510(k) number K961439. 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 ABBOTT CELL-DYN 4000 SYSTEM?

ABBOTT CELL-DYN 4000 SYSTEM is a medical device that received FDA 510(k) clearance on 1996-10-18. The listed applicant is Abbott Diagnostics. The 510(k) number is K961439.

When did ABBOTT CELL-DYN 4000 SYSTEM receive FDA 510(k) clearance?

ABBOTT CELL-DYN 4000 SYSTEM received FDA 510(k) clearance on 1996-10-18, under 510(k) number K961439.

Who is the listed applicant for ABBOTT CELL-DYN 4000 SYSTEM?

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

What is the FDA product code for ABBOTT CELL-DYN 4000 SYSTEM?

The FDA product code for ABBOTT CELL-DYN 4000 SYSTEM is GKZ.

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Other records listing Abbott Diagnostics 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.