LEWIS BLOOD GROUP SUBSTANCE— 510(k) K771487

Name: FDA 510(k) clearance K771487
Creator: U.S. Food and Drug Administration
Published: 1977-11-08

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K771487 for LEWIS BLOOD GROUP SUBSTANCE, Substantially Equivalent on 1977-11-08. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code KSX
Device class: Class 2
Regulation: 21 CFR 864.9160
Advisory panel: Hematology
Date received: 1977-08-05
Decision date: 1977-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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