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FDA 510(k)

ABBOTT CELL-DYN 3500R SYSTEM

K-Number: K960427 · 1996-05-02

ApplicantSequoia Turner Corp.
Decision Date1996-05-02
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABBOTT CELL-DYN 3500R SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sequoia Turner Corp.. It received FDA 510(k) clearance on 1996-05-02 under 510(k) number K960427. 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 3500R SYSTEM?

ABBOTT CELL-DYN 3500R SYSTEM is a medical device that received FDA 510(k) clearance on 1996-05-02. The listed applicant is Sequoia Turner Corp.. The 510(k) number is K960427.

When did ABBOTT CELL-DYN 3500R SYSTEM receive FDA 510(k) clearance?

ABBOTT CELL-DYN 3500R SYSTEM received FDA 510(k) clearance on 1996-05-02, under 510(k) number K960427.

Who is the listed applicant for ABBOTT CELL-DYN 3500R SYSTEM?

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

What is the FDA product code for ABBOTT CELL-DYN 3500R SYSTEM?

The FDA product code for ABBOTT CELL-DYN 3500R SYSTEM is GKZ.

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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.

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