FDA 510(k)

RNARETAIN

K-Number: K113420 · 2012-03-16

Decision Date2012-03-16

Product CodeOZF

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

RNARETAIN is the device name listed in this FDA 510(k) record. The listed applicant is Asuragen, Inc.. It received FDA 510(k) clearance on 2012-03-16 under 510(k) number K113420. The device is classified under product code OZF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RNARETAIN?

RNARETAIN is a medical device that received FDA 510(k) clearance on 2012-03-16. The listed applicant is Asuragen, Inc.. The 510(k) number is K113420.

When did RNARETAIN receive FDA 510(k) clearance?

RNARETAIN received FDA 510(k) clearance on 2012-03-16, under 510(k) number K113420.

Who is the listed applicant for RNARETAIN?

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

What is the FDA product code for RNARETAIN?

The FDA product code for RNARETAIN is OZF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.