Cleared Traditional

CITREX H

K853897 · Bio/Data Corp. · Hematology
Oct 1985
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K853897 is an FDA 510(k) clearance for the CITREX H, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on October 10, 1985, 20 days after receiving the submission on September 20, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K853897 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 1985
Decision Date October 10, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GGW — Test, Time, Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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