Cleared Traditional

K052124 - ACTICLOT, MODEL 824 (FDA 510(k) Clearance)

K052124 · American Diagnostica, Inc. · Hematology device

Oct 2005

Decision

73d

Days

Class 2

Risk

K052124 is an FDA 510(k) clearance for the ACTICLOT, MODEL 824. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).

Submitted by American Diagnostica, Inc. (Stamford, US). The FDA issued a Cleared decision on October 17, 2005, 73 days after receiving the submission on August 5, 2005.

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

Submission Details

510(k) Number	K052124 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 05, 2005
Decision Date	October 17, 2005
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF