International Technidyne Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 47
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0837-2013 | Class II | Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International T | September 28, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS F | July 3, 2013 |
| K050016 | HEMOCHRON SIGNATURE ELITE | February 10, 2005 |
| K030818 | HEMOCHRON RESPONSE/SYSTEM | April 2, 2003 |
| K023561 | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM | January 31, 2003 |
| K020798 | HEMOCHRON JR. SIGNATURE + | March 28, 2002 |
| K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE | July 2, 2001 |
| K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | June 6, 2001 |
| K983475 | HEMOCHRON RESPONSE | May 3, 1999 |
| K990449 | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE | April 13, 1999 |
| K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT | September 30, 1998 |
| K974799 | HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE | July 7, 1998 |
| K972831 | HEMOCHRON CITRATE APTT | November 20, 1997 |
| K961835 | PROTIME MICROCOAGULATION SYSTEM | March 12, 1997 |
| K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | August 12, 1996 |
| K951072 | PROTIME MICROCOAGULATION SYSTEM | October 27, 1995 |
| K945078 | HEMOCHRON HNPT/FACTOR VI PT+ | April 28, 1995 |
| K944691 | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II | March 15, 1995 |
| K940957 | HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM | October 18, 1994 |
| K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | June 30, 1994 |
| K941159 | DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G | May 19, 1994 |