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FDA 510(k)

CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION

K-Number: K991605 · 1999-07-09

ApplicantAbbott Laboratories
Decision Date1999-07-09
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1999-07-09 under 510(k) number K991605. 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 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION?

CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION is a medical device that received FDA 510(k) clearance on 1999-07-09. The listed applicant is Abbott Laboratories. The 510(k) number is K991605.

When did CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION receive FDA 510(k) clearance?

CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION received FDA 510(k) clearance on 1999-07-09, under 510(k) number K991605.

Who is the listed applicant for CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION?

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 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION?

The FDA product code for CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION 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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