FDA.reportPublic FDA data

510(k) K160445

Device
HemosIL Silica Clotting Time
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K160445
Product code
GFO  
Decision
Substantially Equivalent (SESE)
Decision date
2016-03-16
Date received
2016-02-17
Regulation
864.7925
Classification name
Activated Partial Thromboplastin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Heather L Harvey
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 GFO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co.2026-01-09
K193556Cryocheck Hex LAPrecision Biologic2020-10-23
K053111STA-CEPHASCREEN KITDiagnostica Stago, Inc.2006-05-04
K060688HEMOSIL SYNTHASILInstrumentation Laboratory CO2006-04-13
K050221HEMOSIL SILICA CLOTTING TIMEInstrumentation Laboratory CO2005-03-30
K022021VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTTVital Scientific N.V.2002-11-01
K014028CARESIDE APTTCareside Hemotology, Inc.2002-02-08
K014008HEMOCHRON JR. CITRATE APTT CUVETTEItc, Inc.2002-01-24
K992712SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334Sigma Diagnostics, Inc.1999-12-06
K992711SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094Sigma Diagnostics, Inc.1999-12-06
K972831HEMOCHRON CITRATE APTTInternational Technidyne Corp.1997-11-20
K973306IL TEST APTT-SPInstrumentation Laboratory CO1997-11-04
K961892SPECKTIN-LA TEST SETAnalytical Control Systems, Inc.1997-03-07
K955638SYNTHAFAX APTT REAGENTOrtho Diagnostic Systems, Inc.1996-04-23
K955450PATHROMTIN SLBehring Diagnostics, Inc.1996-04-19

Legacy Summary#

summary

FDA Review#

Decision Summary