Cleared Traditional

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)

K011337 · Accumetrics, Inc. · Hematology
Oct 2001
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K011337 is an FDA 510(k) clearance for the ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA), a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Accumetrics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 16, 2001, 167 days after receiving the submission on May 2, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K011337 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2001
Decision Date October 16, 2001
Days to Decision 167 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOZ — System, Automated Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700

Similar Devices — JOZ System, Automated Platelet Aggregation

All 37
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
K191364 · Fujimori Kogyo, Co., Ltd. · Feb 2020
AggreGuide A-100 ADP
K181777 · Aggredyne, Inc. · Mar 2019
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
K163274 · Aggredyne, Inc. · Apr 2017
Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
K161329 · Chrono-Log Corp. · Dec 2016
ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
K141427 · Accumetrics, Inc. · Jul 2015
CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY
K140893 · Coramed Technologies, LLC · Jan 2015