Cleared Traditional

MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL

K881186 · Helps Products, Inc. · Hematology

May 1988

Decision

53d

Days

Class 2

Risk

About This 510(k) Submission

K881186 is an FDA 510(k) clearance for the MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL, a Hematocrit, Tube, Rack, Sealer, Holder (Class II — Special Controls, product code GHY), submitted by Helps Products, Inc. (Orlando, US). The FDA issued a Cleared decision on May 13, 1988, 53 days after receiving the submission on March 21, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number	K881186 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 1988
Decision Date	May 13, 1988
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—