Cleared Traditional

MICROSPIN 24

K953519 · Vulcon Technologies · Hematology

Nov 1995

Decision

99d

Days

Class 2

Risk

About This 510(k) Submission

K953519 is an FDA 510(k) clearance for the MICROSPIN 24, a Instrument, Hematocrit, Automated (Class II — Special Controls, product code GKF), submitted by Vulcon Technologies (Grandview, US). The FDA issued a Cleared decision on November 3, 1995, 99 days after receiving the submission on July 27, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5600.

Submission Details

510(k) Number	K953519 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 1995
Decision Date	November 03, 1995
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement