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FDA 510(k)

CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE

K-Number: K012934 · 2001-09-28

ApplicantAbbott Laboratories
Decision Date2001-09-28
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2001-09-28 under 510(k) number K012934. 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 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE?

CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is Abbott Laboratories. The 510(k) number is K012934.

When did CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE receive FDA 510(k) clearance?

CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE received FDA 510(k) clearance on 2001-09-28, under 510(k) number K012934.

Who is the listed applicant for CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE?

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 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE?

The FDA product code for CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE 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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