Cleared Traditional

MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS

K943571 · More Diagnostics · Hematology

Jun 1995

Decision

331d

Days

Class 2

Risk

About This 510(k) Submission

K943571 is an FDA 510(k) clearance for the MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on June 15, 1995, 331 days after receiving the submission on July 19, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K943571 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 1994
Decision Date	June 15, 1995
Days to Decision	331 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement

Device Classification

Product Code	DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.7320