Cleared Traditional

THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT

K852512 · Pacific Hemostasis · Hematology
Sep 1985
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K852512 is an FDA 510(k) clearance for the THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT, a Fibrin Split Products (Class II — Special Controls, product code GHH), submitted by Pacific Hemostasis (Ventura, US). The FDA issued a Cleared decision on September 17, 1985, 97 days after receiving the submission on June 12, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K852512 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1985
Decision Date September 17, 1985
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GHH — Fibrin Split Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320

Similar Devices — GHH Fibrin Split Products

All 27
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
K112120 · Diazyme Laboratories · Jan 2013
PATHFAST D-DIMER
K072288 · Mitsubishi Kagaku Iatron · May 2009
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
K070453 · Olympus Life & Material Science Europa GmbH (Irish · Jun 2007
TINA-QUANT D-DIMER TEST SYSTEM
K062203 · Roche Diagnostics Corp. · Mar 2007
TRIAGE D-DIMER TEST, MODEL 98100
K042890 · Biosite Incorporated · Nov 2004
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
K030740 · Roche Diagnostics Corp. · Apr 2003