REAGENT CONFIDENCE SERA— 510(k) K771814

Name: FDA 510(k) clearance K771814
Creator: U.S. Food and Drug Administration
Published: 1977-11-07

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K771814 for REAGENT CONFIDENCE SERA, Substantially Equivalent on 1977-11-07. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code KSF
Device class: Class 2
Regulation: 21 CFR 864.9650
Advisory panel: Hematology
Date received: 1977-09-27
Decision date: 1977-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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