Medical Device Manufacturer · US , Walker , MI

International Technidyne Corp.

47 submissions · 47 cleared · Since 1983
47
Total
47
Cleared
0
Denied

International Technidyne Corp. — FDA 510(k) Submissions

International Technidyne Corp. has submitted 47 FDA 510(k) premarket notifications since 1983, of which 47 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Multipurpose For In Vitro Coagulation Studies, Test, Time, Prothrombin, Activated Partial Thromboplastin, Plasma, Coagulation Control, Activated Whole Blood Clotting Time . Use the specialty filter in the sidebar to narrow results.

47 devices
1–25 of 47
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
K120977 · GGN Plasma, Coagulation Control · Hematology
Jul 2013 457d
HEMOCHRON SIGNATURE ELITE
K050016 · JPA System, Multipurpose For... · Hematology
Feb 2005 37d
HEMOCHRON RESPONSE/SYSTEM
K030818 · JPA System, Multipurpose For... · Hematology
Apr 2003 19d
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561 · GKR System, Hemoglobin,... · Hematology
Jan 2003 100d
HEMOCHRON JR. SIGNATURE +
K020798 · JPA System, Multipurpose For... · Hematology
Mar 2002 16d
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
K010599 · GJS Test, Time, Prothrombin · Hematology
Jul 2001 124d
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
K010193 · KFF Assay, Heparin · Hematology
Jun 2001 135d
HEMOCHRON RESPONSE
K983475 · KQG Instrument, Coagulation · Hematology
May 1999 213d
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
K990449 · JPA System, Multipurpose For... · Hematology
Apr 1999 60d
HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT
K972866 · GJS Test, Time, Prothrombin · Hematology
Sep 1998 422d
HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
K974799 · JPA System, Multipurpose For... · Hematology
Jul 1998 197d
HEMOCHRON CITRATE APTT
K972831 · GFO Activated Partial... · Hematology
Nov 1997 113d
PROTIME MICROCOAGULATION SYSTEM
K961835 · GJS Test, Time, Prothrombin · Hematology
Mar 1997 303d
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
K960749 · JBP Activated Whole Blood... · Hematology
Aug 1996 171d
PROTIME MICROCOAGULATION SYSTEM
K951072 · GKP Instrument, Coagulation,... · Hematology
Oct 1995 233d
HEMOCHRON HNPT/FACTOR VI PT+
K945078 · GJS Test, Time, Prothrombin · Hematology
Apr 1995 193d
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
K944691 · GGN Plasma, Coagulation Control · Hematology
Mar 1995 173d
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
K940957 · JPA System, Multipurpose For... · Hematology
Oct 1994 231d
CATALOG NO. J-ACT+ & QC-ACT+
K941007 · JBP Activated Whole Blood... · Hematology
Jun 1994 121d
DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G
K941159 · JKA Tubes, Vials, Systems,... · Chemistry
May 1994 69d
MICROCOAGULATION PROTHROMBIN TIME TEST
K940432 · GJS Test, Time, Prothrombin · Hematology
May 1994 107d
JR. MICROCOAGULATION SYSTEM
K940401 · JPA System, Multipurpose For... · Hematology
May 1994 104d
DIRECTDRAW SUPERSERUM-MINI
K935081 · JKA Tubes, Vials, Systems,... · Chemistry
Jan 1994 78d
HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT
K924637 · GFO Activated Partial... · Hematology
Jan 1993 148d
TENDERLETT FINGER
K923302 · FMK Single Use Only Blood... · General & Plastic Surgery
Jan 1993 200d
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