CMV-VUE(TM) CMV ANTIGEN DETECTION KIT— 510(k) K921616

Substantially Equivalent for Some Indications

Incstar Corp.

FDA 510(k) clearance K921616 for CMV-VUE(TM) CMV ANTIGEN DETECTION KIT, Substantially Equivalent for Some Indications on 1992-08-11. Applicant: Incstar Corp..

Clearance details

Applicant
Incstar Corp.
Product code
Code LIN
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Stillwater, MN, US
Download summary PDFView on FDA.gov ↗

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