Cleared Traditional

K993678 - THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
(FDA 510(k) Clearance)

K993678 · Haemoscope Corp. · Hematology

May 2000

Decision

186d

Days

Class 2

Risk

K993678 is an FDA 510(k) clearance for the THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Haemoscope Corp. (Skokie, US). The FDA issued a Cleared decision on May 5, 2000, 186 days after receiving the submission on November 1, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number	K993678 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 1999
Decision Date	May 05, 2000
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF