PLASMA COAGULATION CONT., ABNORMAL— 510(k) K781104

Name: FDA 510(k) clearance K781104
Creator: U.S. Food and Drug Administration
Published: 1978-08-10

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K781104 for PLASMA COAGULATION CONT., ABNORMAL, Substantially Equivalent on 1978-08-10. Applicant: Ortho Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1978-07-03
Decision date: 1978-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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