ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM— 510(k) K132726

Substantially Equivalent

Primeradx

FDA 510(k) clearance K132726 for ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM, Substantially Equivalent on 2013-11-29. Applicant: Primeradx.

Clearance details

Applicant: Primeradx
Product code: Code OZN
Advisory panel: Microbiology
Date received: 2013-08-30
Decision date: 2013-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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