FDA 510(k)

NEONATAL BIOTINIDASE KIT, MODEL 3018

K-Number: K090123 · 2010-03-05

Decision Date2010-03-05

Product CodeNAK

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

NEONATAL BIOTINIDASE KIT, MODEL 3018 is the device name listed in this FDA 510(k) record. The listed applicant is Perkinelmer, Inc.. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K090123. The device is classified under product code NAK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL BIOTINIDASE KIT, MODEL 3018?

NEONATAL BIOTINIDASE KIT, MODEL 3018 is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K090123.

When did NEONATAL BIOTINIDASE KIT, MODEL 3018 receive FDA 510(k) clearance?

NEONATAL BIOTINIDASE KIT, MODEL 3018 received FDA 510(k) clearance on 2010-03-05, under 510(k) number K090123.

Who is the listed applicant for NEONATAL BIOTINIDASE KIT, MODEL 3018?

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

What is the FDA product code for NEONATAL BIOTINIDASE KIT, MODEL 3018?

The FDA product code for NEONATAL BIOTINIDASE KIT, MODEL 3018 is NAK.

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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.