Cleared Traditional

TRACE TRANSFERRIN REAGENT

K932713 · Trace Scientific , Ltd. · Hematology

Sep 1993

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K932713 is an FDA 510(k) clearance for the TRACE TRANSFERRIN REAGENT, a Antigen, Antiserum, Control, Antithrombin Iii (Class II — Special Controls, product code DDQ), submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on September 30, 1993, 118 days after receiving the submission on June 4, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number	K932713 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 1993
Decision Date	September 30, 1993
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement