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FDA 510(k)

OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM

K-Number: K113566 · 2012-06-21

ApplicantLife Technologies, Inc.
Decision Date2012-06-21
Product CodeNDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM is the device name listed in this FDA 510(k) record. The listed applicant is Life Technologies, Inc.. It received FDA 510(k) clearance on 2012-06-21 under 510(k) number K113566. The device is classified under product code NDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM?

OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM is a medical device that received FDA 510(k) clearance on 2012-06-21. The listed applicant is Life Technologies, Inc.. The 510(k) number is K113566.

When did OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM receive FDA 510(k) clearance?

OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM received FDA 510(k) clearance on 2012-06-21, under 510(k) number K113566.

Who is the listed applicant for OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM?

The FDA 510(k) record lists Life Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM?

The FDA product code for OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM is NDS.

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Related Devices (Code: NDS)

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Official Source

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