ASSAY, CHROMOGENIC ANTITHROMBIN III— 510(k) K781860

Name: FDA 510(k) clearance K781860
Creator: U.S. Food and Drug Administration
Published: 1978-12-04

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K781860 for ASSAY, CHROMOGENIC ANTITHROMBIN III, Substantially Equivalent on 1978-12-04. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1978-11-06
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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