Cleared Traditional

STA D-DI CALIBRATOR KIT

K964718 · American Bioproducts Co. · Hematology

May 1997

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K964718 is an FDA 510(k) clearance for the STA D-DI CALIBRATOR KIT, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on May 23, 1997, 179 days after receiving the submission on November 25, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K964718 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 1996
Decision Date	May 23, 1997
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF

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