Cleared Traditional

K854546 - MICROSAMPLE COAGULATION ANALYSER MODEL 110P
(FDA 510(k) Clearance)

K854546 · Bio/Data Corp. · Hematology

Jan 1986

Decision

55d

Days

Class 2

Risk

K854546 is an FDA 510(k) clearance for the MICROSAMPLE COAGULATION ANALYSER MODEL 110P, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on January 7, 1986, 55 days after receiving the submission on November 13, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number	K854546 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 1985
Decision Date	January 07, 1986
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—