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FDA 510(k) Applications Submitted by JOHN CLAY
FDA 510(k) Number
Submission Date
Device Name
Applicant
K010193
01/22/2001
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
INTERNATIONAL TECHNIDYNE CORP.
K990449
02/12/1999
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
INTERNATIONAL TECHNIDYNE CORP.
K010599
02/28/2001
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
INTERNATIONAL TECHNIDYNE CORP.
K020798
03/12/2002
HEMOCHRON JR. SIGNATURE +
INTERNATIONAL TECHNIDYNE CORP.
K030818
03/14/2003
HEMOCHRON RESPONSE/SYSTEM
INTERNATIONAL TECHNIDYNE CORP.
K050786
03/28/2005
BARRIER SURGICAL GOWNS
MOLNLYCKE HEALTH CARE
K100921
04/02/2010
ADMIRAL XTREME PTA BALLOON DILATATION CATHETER
INVATEC S.P.A.
K051625
06/20/2005
BARRIER SURGICAL DRAPES
MOLNLYCKE HEALTH CARE, INC.
K092361
08/04/2009
REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER
INVATEC S.P.A.
K132870
09/13/2013
Origio Gas Line Filter
ORIGIO, INC
K023561
10/23/2002
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
INTERNATIONAL TECHNIDYNE CORP.
K014008
12/05/2001
HEMOCHRON JR. CITRATE APTT CUVETTE
ITC, INC.
K983475
10/02/1998
HEMOCHRON RESPONSE
INTERNATIONAL TECHNIDYNE CORP.
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