Cleared Traditional

THROMBOSCREEN APTT REAGENT

K891337 · Pacific Hemostasis · Hematology
Apr 1989
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K891337 is an FDA 510(k) clearance for the THROMBOSCREEN APTT REAGENT, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Pacific Hemostasis (Ventura, US). The FDA issued a Cleared decision on April 21, 1989, 42 days after receiving the submission on March 10, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K891337 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1989
Decision Date April 21, 1989
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GFO — Activated Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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