Cleared Traditional

K943153 - MICROSAMPLE COAGULATION ANALYZER
(FDA 510(k) Clearance)

K943153 · Bio/Data Corp. · Hematology

Mar 1995

Decision

267d

Days

Class 2

Risk

K943153 is an FDA 510(k) clearance for the MICROSAMPLE COAGULATION ANALYZER. This device is classified as a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP).

Submitted by Bio/Data Corp. (Horsham, US). The FDA issued a Cleared decision on March 24, 1995, 267 days after receiving the submission on June 30, 1994.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5400.

Submission Details

510(k) Number	K943153 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 1994
Decision Date	March 24, 1995
Days to Decision	267 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF