Cleared Traditional

THROMBOSCREEN THROMBOPLASTIN-DS

K940082 · Pacific Hemostasis · Hematology
Feb 1995
Decision
403d
Days
Class 2
Risk

About This 510(k) Submission

K940082 is an FDA 510(k) clearance for the THROMBOSCREEN THROMBOPLASTIN-DS, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on February 14, 1995, 403 days after receiving the submission on January 7, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K940082 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 1994
Decision Date February 14, 1995
Days to Decision 403 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750