PACIFIC HEMOSTASIS THROMBOSCREEN 400C— 510(k) K992130

Name: FDA 510(k) clearance K992130
Creator: U.S. Food and Drug Administration
Published: 1999-09-03

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K992130 for PACIFIC HEMOSTASIS THROMBOSCREEN 400C, Substantially Equivalent on 1999-09-03. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code KQG
Device class: Class 2
Regulation: 21 CFR 864.5400
Advisory panel: Hematology
Date received: 1999-06-23
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntersville, NC, US

Download summary PDF View on FDA.gov ↗

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