COAGULATION CONTROL LEVEL 3 (ABNORMAL)— 510(k) K984131

Name: FDA 510(k) clearance K984131
Creator: U.S. Food and Drug Administration
Published: 1998-12-01

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K984131 for COAGULATION CONTROL LEVEL 3 (ABNORMAL), Substantially Equivalent on 1998-12-01. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code GGC
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1998-11-18
Decision date: 1998-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntersville, NC, US

Download summary PDF View on FDA.gov ↗

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