Cleared Traditional

SAFECRIT PLASTIC MICROHEMATOCRIT TUBES

K883185 · Norfolk Scientific, Inc. · Hematology

Aug 1988

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K883185 is an FDA 510(k) clearance for the SAFECRIT PLASTIC MICROHEMATOCRIT TUBES, a Hematocrit, Tube, Rack, Sealer, Holder (Class II — Special Controls, product code GHY), submitted by Norfolk Scientific, Inc. (Norwood, US). The FDA issued a Cleared decision on August 18, 1988, 21 days after receiving the submission on July 28, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number	K883185 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 1988
Decision Date	August 18, 1988
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—