Cleared Traditional

K961835 - PROTIME MICROCOAGULATION SYSTEM
(FDA 510(k) Clearance)

K961835 · International Technidyne Corp. · Hematology device

Mar 1997

Decision

303d

Days

Class 2

Risk

K961835 is an FDA 510(k) clearance for the PROTIME MICROCOAGULATION SYSTEM. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on March 12, 1997, 303 days after receiving the submission on May 13, 1996.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number	K961835 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 13, 1996
Decision Date	March 12, 1997
Days to Decision	303 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF