REAGENT CONFIDENCE SERA— 510(k) K771814

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K771814 for REAGENT CONFIDENCE SERA, Substantially Equivalent on 1977-11-07. Applicant: Ortho Diagnostics, Inc..

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code KSF
Advisory panel: Hematology
Date received: 1977-09-27
Decision date: 1977-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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