THROMBO SCREEN SICKLE CELL ASSAY SET— 510(k) K854079

Name: FDA 510(k) clearance K854079
Creator: U.S. Food and Drug Administration
Published: 1985-10-31

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K854079 for THROMBO SCREEN SICKLE CELL ASSAY SET, Substantially Equivalent on 1985-10-31. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code GHM
Device class: Class 2
Regulation: 21 CFR 864.7825
Advisory panel: Hematology
Date received: 1985-10-07
Decision date: 1985-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.