Cleared Traditional

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2

K932657 · More Diagnostics · Hematology

Nov 1993

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K932657 is an FDA 510(k) clearance for the FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2, 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 November 2, 1993, 153 days after receiving the submission on June 2, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K932657 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 1993
Decision Date	November 02, 1993
Days to Decision	153 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