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FDA 510(k)

CELL-DYN SAPPHIRE SYSTEM

K-Number: K051215 · 2005-07-21

ApplicantAbbott Laboratories
Decision Date2005-07-21
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELL-DYN SAPPHIRE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2005-07-21 under 510(k) number K051215. 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 SAPPHIRE SYSTEM?

CELL-DYN SAPPHIRE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-07-21. The listed applicant is Abbott Laboratories. The 510(k) number is K051215.

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

CELL-DYN SAPPHIRE SYSTEM received FDA 510(k) clearance on 2005-07-21, under 510(k) number K051215.

Who is the listed applicant for CELL-DYN SAPPHIRE SYSTEM?

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 SAPPHIRE SYSTEM?

The FDA product code for CELL-DYN SAPPHIRE SYSTEM 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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