Cleared Traditional

DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE

K852519 · E.I. Dupont DE Nemours & Co., Inc. · Hematology
Aug 1985
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K852519 is an FDA 510(k) clearance for the DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE, a Bothrops Atrox Reagent (Class II — Special Controls, product code JCO), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on August 12, 1985, 56 days after receiving the submission on June 17, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8100.

Submission Details

510(k) Number K852519 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1985
Decision Date August 12, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JCO — Bothrops Atrox Reagent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8100