Cleared Traditional

UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST

K882325 · Sclavo, Inc. · Hematology

Aug 1988

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K882325 is an FDA 510(k) clearance for the UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on August 25, 1988, 80 days after receiving the submission on June 6, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number	K882325 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 1988
Decision Date	August 25, 1988
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—