ORTHO ANTIBODY ENHANCEMENT SOLUTION— 510(k) K791791

Name: FDA 510(k) clearance K791791
Creator: U.S. Food and Drug Administration
Published: 1979-10-11

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K791791 for ORTHO ANTIBODY ENHANCEMENT SOLUTION, Substantially Equivalent on 1979-10-11. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code KSG
Device class: Class 2
Regulation: 21 CFR 864.9600
Advisory panel: Hematology
Date received: 1979-09-11
Decision date: 1979-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K800310 — ORTHO ANTISERA CONTROL1980-03-05
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