Cleared Traditional

K853078 - CITREX III
(FDA 510(k) Clearance)

K853078 · Bio/Data Corp. · Hematology

Aug 1985

Decision

20d

Days

Class 2

Risk

K853078 is an FDA 510(k) clearance for the CITREX III, 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 August 12, 1985, 20 days after receiving the submission on July 23, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number	K853078 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 1985
Decision Date	August 12, 1985
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—