MICROSAMPLE BLOOD COLLECTION DEVICE— 510(k) K761137

Name: FDA 510(k) clearance K761137
Creator: U.S. Food and Drug Administration
Published: 1977-02-07

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K761137 for MICROSAMPLE BLOOD COLLECTION DEVICE, Substantially Equivalent on 1977-02-07. Applicant: Ortho Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code GKH
Device class: Class 1
Regulation: 21 CFR 864.5240
Advisory panel: Hematology
Date received: 1976-11-24
Decision date: 1977-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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