ORTHO ANTISERA CONTROL— 510(k) K800310

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K800310 for ORTHO ANTISERA CONTROL, Substantially Equivalent on 1980-03-05. Applicant: Ortho Diagnostics, Inc..

Clearance details

Applicant
Ortho Diagnostics, Inc.
Product code
Code KSF
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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