Cleared Traditional

PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560

K010750 · Fisher Diagnostics · Hematology
Sep 2001
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K010750 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on September 7, 2001, 178 days after receiving the submission on March 13, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K010750 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2001
Decision Date September 07, 2001
Days to Decision 178 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGN — Plasma, Coagulation Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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