HEPARIN CONTROL PLASMA LEVEL 2— 510(k) K992279

Name: FDA 510(k) clearance K992279
Creator: U.S. Food and Drug Administration
Published: 1999-08-26

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K992279 for HEPARIN CONTROL PLASMA LEVEL 2, Substantially Equivalent on 1999-08-26. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code GGN
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1999-07-07
Decision date: 1999-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntersville, NC, US

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K000679 — THROMBOSTRATE CONTROL PLASMAS2000-03-24
K994100 — PACIFIC HEMOSTASIS THROMBOPLASTIN D2000-02-18
K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C1999-09-03
K992278 — HEPARIN CONTROL PLASMA LEVEL 11999-08-26
K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 2001999-06-21

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