Cleared Traditional

HEMATASTAT C-70B

K913128 · Separation Technology, Inc. · Hematology

Sep 1991

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K913128 is an FDA 510(k) clearance for the HEMATASTAT C-70B, a Centrifuge, Hematocrit (Class II — Special Controls, product code GKG), submitted by Separation Technology, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 23, 1991, 136 days after receiving the submission on May 10, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number	K913128 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 1991
Decision Date	September 23, 1991
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement