Cleared Traditional

CARESIDE PT

K991065 · Careside, Inc. · Hematology
Jul 1999
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K991065 is an FDA 510(k) clearance for the CARESIDE PT, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on July 26, 1999, 117 days after receiving the submission on March 31, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K991065 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1999
Decision Date July 26, 1999
Days to Decision 117 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