Company ยท US
International Technidyne Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2013. Name variants (Inc, Corp, punctuation) are merged.
48510(k) clearances (0 in 12 months)
22recalls (0 in 12 months)
20recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GJS | Test, Time, Prothrombin | 13 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 11 |
| GGN | Plasma, Coagulation Control | 8 |
| JBP | Activated Whole Blood Clotting Time | 6 |
| GFO | Activated Partial Thromboplastin | 5 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 4 |
| DQA | Oximeter | 3 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 |
| KFF | Assay, Heparin | 3 |
| JCA | Device, Bleeding Time | 2 |
| KQG | Instrument, Coagulation | 2 |
| GFT | Protamine Sulphate | 1 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 1 |
| GJA | Test, Thrombin Time | 1 |
| GKP | Instrument, Coagulation, Automated | 1 |
| GKR | System, Hemoglobin, Automated | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JKS | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide | 1 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 1 |
| KQJ | System, Fibrinogen Determination | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 2013 | K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC International Technidyne Corp. | GGN |
| May 16, 2005 | K050983 | IRMA TRUPOINT CREATININE CONTROL KIT International Technidyne Corporation | JJX |
| Feb 10, 2005 | K050016 | HEMOCHRON SIGNATURE ELITE International Technidyne Corp. | JPA |
| Apr 2, 2003 | K030818 | HEMOCHRON RESPONSE/SYSTEM International Technidyne Corp. | JPA |
| Jan 31, 2003 | K023561 | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM International Technidyne Corp. | GKR |
| Mar 28, 2002 | K020798 | HEMOCHRON JR. SIGNATURE + International Technidyne Corp. | JPA |
| Jul 2, 2001 | K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE International Technidyne Corp. | GJS |
| Jun 6, 2001 | K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS International Technidyne Corp. | KFF |
| May 3, 1999 | K983475 | HEMOCHRON RESPONSE International Technidyne Corp. | KQG |
| Apr 13, 1999 | K990449 | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE International Technidyne Corp. | JPA |
| Sep 30, 1998 | K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT International Technidyne Corp. | GJS |
| Jul 7, 1998 | K974799 | HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE International Technidyne Corp. | JPA |
| Nov 20, 1997 | K972831 | HEMOCHRON CITRATE APTT International Technidyne Corp. | GFO |
| Mar 12, 1997 | K961835 | PROTIME MICROCOAGULATION SYSTEM International Technidyne Corp. | GJS |
| Aug 12, 1996 | K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT International Technidyne Corp. | JBP |
| Oct 27, 1995 | K951072 | PROTIME MICROCOAGULATION SYSTEM International Technidyne Corp. | GKP |
| Apr 28, 1995 | K945078 | HEMOCHRON HNPT/FACTOR VI PT+ International Technidyne Corp. | GJS |
| Mar 15, 1995 | K944691 | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II International Technidyne Corp. | GGN |
| Oct 18, 1994 | K940957 | HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM International Technidyne Corp. | JPA |
| Jun 30, 1994 | K941007 | CATALOG NO. J-ACT+ & QC-ACT+ International Technidyne Corp. | JBP |
| May 19, 1994 | K941159 | DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G International Technidyne Corp. | JKA |
| May 18, 1994 | K940432 | MICROCOAGULATION PROTHROMBIN TIME TEST International Technidyne Corp. | GJS |
| May 11, 1994 | K940401 | JR. MICROCOAGULATION SYSTEM International Technidyne Corp. | JPA |
| Jan 11, 1994 | K935081 | DIRECTDRAW SUPERSERUM-MINI International Technidyne Corp. | JKA |
| Jan 27, 1993 | K924637 | HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT International Technidyne Corp. | GFO |
| Jan 22, 1993 | K923302 | TENDERLETT FINGER International Technidyne Corp. | FMK |
| Jan 21, 1993 | K923761 | ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM International Technidyne Corp. | JPA |
| Jan 14, 1993 | K924638 | HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT International Technidyne Corp. | GFO |
| Sep 22, 1992 | K923593 | HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS International Technidyne Corp. | KQJ |
| May 28, 1992 | K921778 | DIRECTDRAW SUPERSERUM International Technidyne Corp. | GIM |
| Feb 11, 1992 | K915344 | HEMOCHRON ONESTEP APTT TEST International Technidyne Corp. | GFO |
| Oct 18, 1991 | K913861 | HEMOCHRON(R) KACT International Technidyne Corp. | JBP |
| Jul 17, 1991 | K911997 | TENDERFOOT(R), MODIFICATION International Technidyne Corp. | FMK |
| Jul 17, 1991 | K911996 | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION International Technidyne Corp. | JCA |
| Jul 17, 1991 | K911995 | PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION International Technidyne Corp. | GJS |
| Jul 17, 1991 | K911994 | HEMOCHRON(R) APTT, MODIFICATION International Technidyne Corp. | GFO |
| May 10, 1991 | K910646 | SUPERSERUM REAGENT (SSR) International Technidyne Corp. | JKA |
| May 10, 1991 | K910181 | HITT BY HEMOCHRON(R) International Technidyne Corp. | KFF |
| Feb 26, 1991 | K910105 | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 International Technidyne Corp. | GFT |
| Dec 17, 1990 | K904454 | HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION International Technidyne Corp. | GJS |
| Feb 5, 1990 | K900126 | TT AND HNTT BY HEMOCHRON International Technidyne Corp. | GJA |
| Jun 22, 1989 | K893378 | PROTHROMBIN TIME (PT) BY HEMOCHRON International Technidyne Corp. | GJS |
| Dec 1, 1988 | K883968 | TENDERFOOT International Technidyne Corp. | FMK |
| Aug 30, 1988 | K882481 | HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II International Technidyne Corp. | GGN |
| Aug 30, 1988 | K882480 | HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II International Technidyne Corp. | GGN |
| Jun 1, 1987 | K870831 | PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA International Technidyne Corp. | JPA |
| Mar 1, 1985 | K850542 | SURGICUTT - BLEEDING TIME DEVICE International Technidyne Corp. | JCA |
| Oct 14, 1983 | K832189 | HEMOCHRON THROMBOCHRONOMETER International Technidyne Corp. | JBP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 19, 2013 | International Technidyne Corp. Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50.
International Technidyne Corporation.
The Pro Time Microcoagulation System is a portable battery operated instrume Terminated |
GJS | K010599 |
| Aug 5, 2011 | International Technidyne Corp. Hemochron JR. Microcoagulation Systems Prothrombin Time (PT).
International Ethidine Corp (ITC)-Nexus Dx.
A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time. Terminated |
JPA | K940432 K974799 |
| Aug 5, 2011 | International Technidyne Corp. IL GEM PCL/PCL Plus - Gem Test PT Cartridge
ITC-Nexus Dx
A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time. Terminated |
JPA | K940432 K974799 |
| May 19, 2011 | International Technidyne Corp. AVOXimeter 1000, AVOXimeter 4000
1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced soft Terminated |
DQA | K951485 |
| Mar 1, 2011 | International Technidyne Corp. Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System.
The system is intended to be used only with test cuvettes that are available from ITC. Terminated |
RFZ | None listed |
| Feb 11, 2011 | International Technidyne Corp. Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date a Terminated |
KQG | K983475 |
| Sep 20, 2010 | International Technidyne Corporation Integrated Data Management System - Version 7.1, 7.2 and 7.3;
ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854 Terminated |
JQP | None listed |
| Aug 10, 2010 | International Technidyne Corp. International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic
15 vials
For performance of Level 1 qualit Terminated |
GGN | K944691 |
| Jul 28, 2010 | International Technidyne Corporation GEM Check Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100. 15/pk.
Manufactured for Instrumentation Laboratory Company, Lexington, MA 02421-3125.
Intended to be used t Terminated |
GGN | K944691 |
| Jul 28, 2010 | International Technidyne Corporation GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert:
IVD. 15/pk. 06260061600.
Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125.
Intended to be used Terminated |
GGN | K944691 |
| Jul 28, 2010 | International Technidyne Corp. RQCHRT HRT Control Level 1 & 2;
Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes.
20 vials Whole Blood - 2.0mL; dried
20 vials Diluent - 4.0 mL
The Hemochron HRT Whole Blo Terminated |
KFF | K904003 |
| Jun 11, 2010 | International Technidyne Corporation directCHECK Whole Blood Control;
for Hemochron J. Microcoagulation Systems. Terminated |
GGN | K944691 |
| Aug 21, 2009 | International Technidyne Corp. Hemochron Jr. ACT- LR Assay (JACT- LR);
ITC Catalogue/Code Number: JACTLR
45 Cuvettes;
For Performance on the HEMOCHROM Whole Blood Microagulation Systems;
International Technidyne Corp., Edison, NJ 0 Terminated |
JBP | K960749 |
| Aug 6, 2008 | International Technidyne Corp. International Technidyne Corp. (ITC) AVOXimeter 4000 Co-oximeter, Catalog Numbers: AVOX4000-110 and AVOX4000-220 Terminated |
JKS | K951485 |
| Aug 6, 2008 | International Technidyne Corp. International Technidyne Corp. (ITC) AVOXimeter 1000E Oximeter, Catalog Numbers: AVOX1000E-110 and AVOX1000E-220 Terminated |
DQA | K922075 |
| Aug 6, 2008 | International Technidyne Corp. International Technidyne Corp. (ITC) AVOXimeter 1000 Oximeter, Catalog Numbers: AVON1000-110 and AVOX-1000-220 Terminated |
DQA | K922075 |
| Jan 25, 2008 | International Technidyne Corporation ProTime Microcoagulation System Instrument:Catalogue Number:
PROTIMEINT, International Technidyne Corporation (ITC), Piscataway, NJ 08854 Terminated |
GJS | K951072 |
| Jan 25, 2008 | International Technidyne Corporation ProTime Microcoagulation System Instrument, Catalogue Number:
PROTIMEPST, International Technidyne Corporation (ITC), Piscataway, NJ 08854 Terminated |
GJS | K961835 |
| Jan 25, 2008 | International Technidyne Corporation ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, International Technidyne Corporation (ITC), Piscataway, NJ 08854 Terminated |
GJS | K010599 |
| Jan 13, 2007 | International Technidyne Corp. International Technidyne Corporation (ITC) ProTime Microcoagulation System Instrument-Catalogue Number-Protimeint & Protimepro, Protimeintrf & Protimeprorf, Protimeintl & Protimeprol. Terminated |
GJS | K951072 |
| Mar 23, 2006 | International Technidyne Corp Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use. Terminated |
FMK | K923302 |
| Aug 23, 2005 | International Technidyne Corp. Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per Terminated |
JBP | K960749 |