Cleared Traditional

THROMBOPLASTIN WITH CALCIUM

K902096 · Sigma Chemical Co. · Hematology
Jul 1990
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K902096 is an FDA 510(k) clearance for the THROMBOPLASTIN WITH CALCIUM, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on July 3, 1990, 56 days after receiving the submission on May 8, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K902096 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1990
Decision Date July 03, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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