Cleared Traditional

CITREX I

K853076 · Bio/Data Corp. · Hematology
Aug 1985
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K853076 is an FDA 510(k) clearance for the CITREX I, 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 K853076 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 —

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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