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FDA 510(k)

ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)

K-Number: K971152 · 1997-08-12

ApplicantAbbott Laboratories
Decision Date1997-08-12
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1997-08-12 under 510(k) number K971152. 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 IMMATURE RETICULOCYTE FRACTION (IRF)?

ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) is a medical device that received FDA 510(k) clearance on 1997-08-12. The listed applicant is Abbott Laboratories. The 510(k) number is K971152.

When did ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) receive FDA 510(k) clearance?

ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) received FDA 510(k) clearance on 1997-08-12, under 510(k) number K971152.

Who is the listed applicant for ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)?

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 ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)?

The FDA product code for ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) 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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