MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT— 510(k) K864565

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K864565 for MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT, Substantially Equivalent on 1987-02-19. Applicant: Serono Diagnostics, Inc..

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code GQH
Advisory panel: Microbiology
Date received: 1986-11-19
Decision date: 1987-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

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