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FDA 510(k)

ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM

K-Number: K132726 · 2013-11-29

ApplicantPrimeradx
Decision Date2013-11-29
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Primeradx. It received FDA 510(k) clearance on 2013-11-29 under 510(k) number K132726. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM?

ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-29. The listed applicant is Primeradx. The 510(k) number is K132726.

When did ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM receive FDA 510(k) clearance?

ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM received FDA 510(k) clearance on 2013-11-29, under 510(k) number K132726.

Who is the listed applicant for ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM?

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

What is the FDA product code for ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM?

The FDA product code for ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM is OZN.

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Official Source

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