Cleared Traditional

PROTHROMBIN TIME TEST

K870596 · U. S. Diagnostics, Inc. · Hematology
Apr 1987
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K870596 is an FDA 510(k) clearance for the PROTHROMBIN TIME TEST, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on April 20, 1987, 69 days after receiving the submission on February 10, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K870596 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1987
Decision Date April 20, 1987
Days to Decision 69 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