Cleared Traditional

THROMBOPLASTIN

K810350 · Pacific Hemostasis · Immunology
Apr 1981
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K810350 is an FDA 510(k) clearance for the THROMBOPLASTIN, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Pacific Hemostasis (Walker, US). The FDA issued a Cleared decision on April 14, 1981, 63 days after receiving the submission on February 10, 1981. This device falls under the Immunology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K810350 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1981
Decision Date April 14, 1981
Days to Decision 63 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

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