FETALSCREEN— 510(k) K820199

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K820199 for FETALSCREEN, Substantially Equivalent on 1982-05-12. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant
Ortho Diagnostic Systems, Inc.
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carpinteria, CA, US
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