Cleared Traditional

STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES

K903698 · Statspin Technologies · Hematology

Sep 1990

Decision

33d

Days

Class 2

Risk

About This 510(k) Submission

K903698 is an FDA 510(k) clearance for the STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES, a Device, Hematocrit Measuring (Class II — Special Controls, product code JPI), submitted by Statspin Technologies (Norwood, US). The FDA issued a Cleared decision on September 17, 1990, 33 days after receiving the submission on August 15, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number	K903698 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 1990
Decision Date	September 17, 1990
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—