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510(k) K160415

Device
GEM Premier 5000 (Measured Parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
Applicant
Instrumentation Laboratory Co.
510(k) number
K160415
Product code
GKF  
Decision
Substantially Equivalent (SESE)
Decision date
2016-12-14
Date received
2016-02-12
Regulation
864.5600
Classification name
Instrument, Hematocrit, Automated
Medical specialty
Hematology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Carol Marble
Address
180 Hartwell Rd. Bedford MA US 01730 01730

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GKF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K983551CRIT-SCAN II MONITORIn-Line Diagnostics Corp.1999-05-27
K981425STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERSNova Biomedical Corp.1998-05-12
K981426STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERSNova Biomedical Corp.1998-05-12
K981427STAT PROFILE M ANALYZERNova Biomedical Corp.1998-05-12
K953519MICROSPIN 24Vulcon Technologies1995-11-03
K915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEFisher Scientific Co., LLC1992-03-11
K915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEFisher Scientific Co., LLC1992-01-08
K904336NEW COBE SATURATION/HEMATOCRIT MONITORCobe Laboratories, Inc.1990-12-27
K880373IONOMETER E-HK AND ACCESSORIESSmash Ent., Inc.1988-03-17
K870860CHEMPRO 1000(TM)Arden Medical Systems, Inc.1987-04-14
K864646SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGEE.I. Dupont DE Nemours & Co., Inc.1987-01-05
K864039MICROHEMATOCRIT CENTRIFUGEPlaza Medical, Inc.1986-10-29
K802199STAT-CRIT HEMATOCRIT MEASURING INSTRUUnited States Surgical, A Division of Tyco Healthc1981-02-04
K781059CUTTER/COMPUR MINI CENTRIFUGECutter Laboratories, Inc.1978-08-14

Legacy Summary#

summary

FDA Review#

Decision Summary