THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT— 510(k) K852512

Name: FDA 510(k) clearance K852512
Creator: U.S. Food and Drug Administration
Published: 1985-09-17

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K852512 for THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT, Substantially Equivalent on 1985-09-17. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1985-06-12
Decision date: 1985-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

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