Cleared Traditional

PACIFIC HEMOSTASIS THROMBOPLASTIN D

K994100 · Pacific Hemostasis · Hematology
Feb 2000
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K994100 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS THROMBOPLASTIN D, 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 18, 2000, 77 days after receiving the submission on December 3, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K994100 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1999
Decision Date February 18, 2000
Days to Decision 77 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