DeviceClearance

D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT— 510(k) K081164

Substantially Equivalent

Diagnostic Hybrids, Inc.

FDA 510(k) clearance K081164 for D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT, Substantially Equivalent on 2008-06-13. Applicant: Diagnostic Hybrids, Inc..

Clearance details

Applicant
Diagnostic Hybrids, Inc.
Product code
Code LIN
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Athens, OH, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.