PACIFIC HEMOSTASIS THROMBOSCREEN 200— 510(k) K991321

Name: FDA 510(k) clearance K991321
Creator: U.S. Food and Drug Administration
Published: 1999-06-21

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K991321 for PACIFIC HEMOSTASIS THROMBOSCREEN 200, Substantially Equivalent on 1999-06-21. 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: 1999-04-19
Decision date: 1999-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntersville, NC, US

Download summary PDF View on FDA.gov ↗

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K992279 — HEPARIN CONTROL PLASMA LEVEL 21999-08-26
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