Cleared Traditional

CEPHALINEX ACTIVATED PTT REAGENT

K852195 · Bio/Data Corp. · Hematology
Aug 1985
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K852195 is an FDA 510(k) clearance for the CEPHALINEX ACTIVATED PTT REAGENT, 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 August 12, 1985, 84 days after receiving the submission on May 20, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K852195 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1985
Decision Date August 12, 1985
Days to Decision 84 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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