Cleared Traditional

DATA-FI DIMERTEST LATEX ASSAY

K872195 · American Dade · Hematology

Aug 1987

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K872195 is an FDA 510(k) clearance for the DATA-FI DIMERTEST LATEX ASSAY, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on August 6, 1987, 59 days after receiving the submission on June 8, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K872195 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 1987
Decision Date	August 06, 1987
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—

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