PLASMINOGEN ASSAY— 510(k) K781478

Name: FDA 510(k) clearance K781478
Creator: U.S. Food and Drug Administration
Published: 1978-11-15

Substantially Equivalent

Dade, Baxter Travenol Diagnostics, Inc.

FDA 510(k) clearance K781478 for PLASMINOGEN ASSAY, Substantially Equivalent on 1978-11-15. Applicant: Dade, Baxter Travenol Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Dade, Baxter Travenol Diagnostics, Inc.
Product code: Code DDX
Device class: Class 1
Regulation: 21 CFR 866.5715
Advisory panel: Immunology
Date received: 1978-08-28
Decision date: 1978-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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