Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
International Technidyne Corp. — Predicate Candidate Screening
47 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
231 days90th percentile
47clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTE | International Technidyne Corp. | 2013-07-03 | 457 | 0 |
| K050016 | HEMOCHRON SIGNATURE ELITE | International Technidyne Corp. | 2005-02-10 | 37 | 0 |
| K030818 | HEMOCHRON RESPONSE/SYSTEM | International Technidyne Corp. | 2003-04-02 | 19 | 0 |
| K023561 | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM | International Technidyne Corp. | 2003-01-31 | 100 | 0 |
| K020798 | HEMOCHRON JR. SIGNATURE + | International Technidyne Corp. | 2002-03-28 | 16 | 0 |
| K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE | International Technidyne Corp. | 2001-07-02 | 124 | 3 |
| K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSA | International Technidyne Corp. | 2001-06-06 | 135 | 0 |
| K983475 | HEMOCHRON RESPONSE | International Technidyne Corp. | 1999-05-03 | 213 | 1 |
| K990449 | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE | International Technidyne Corp. | 1999-04-13 | 60 | 0 |
| K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT | International Technidyne Corp. | 1998-09-30 | 422 | 0 |
| K974799 | HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE | International Technidyne Corp. | 1998-07-07 | 197 | 2 |
| K972831 | HEMOCHRON CITRATE APTT | International Technidyne Corp. | 1997-11-20 | 113 | 0 |
| K961835 | PROTIME MICROCOAGULATION SYSTEM | International Technidyne Corp. | 1997-03-12 | 303 | 1 |
| K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | International Technidyne Corp. | 1996-08-12 | 171 | 3 |
| K951072 | PROTIME MICROCOAGULATION SYSTEM | International Technidyne Corp. | 1995-10-27 | 233 | 2 |
| K945078 | HEMOCHRON HNPT/FACTOR VI PT+ | International Technidyne Corp. | 1995-04-28 | 193 | 0 |
| K944691 | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II | International Technidyne Corp. | 1995-03-15 | 173 | 4 |
| K940957 | HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM | International Technidyne Corp. | 1994-10-18 | 231 | 0 |
| K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | International Technidyne Corp. | 1994-06-30 | 121 | 0 |
| K941159 | DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G | International Technidyne Corp. | 1994-05-19 | 69 | 0 |
| K940432 | MICROCOAGULATION PROTHROMBIN TIME TEST | International Technidyne Corp. | 1994-05-18 | 107 | 2 |
| K940401 | JR. MICROCOAGULATION SYSTEM | International Technidyne Corp. | 1994-05-11 | 104 | 1 |
| K935081 | DIRECTDRAW SUPERSERUM-MINI | International Technidyne Corp. | 1994-01-11 | 78 | 0 |
| K924637 | HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT | International Technidyne Corp. | 1993-01-27 | 148 | 0 |
| K923302 | TENDERLETT FINGER | International Technidyne Corp. | 1993-01-22 | 200 | 1 |
| K923761 | ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM | International Technidyne Corp. | 1993-01-21 | 177 | 0 |
| K924638 | HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT | International Technidyne Corp. | 1993-01-14 | 135 | 0 |
| K923593 | HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS | International Technidyne Corp. | 1992-09-22 | 64 | 0 |
| K921778 | DIRECTDRAW SUPERSERUM | International Technidyne Corp. | 1992-05-28 | 44 | 0 |
| K915344 | HEMOCHRON ONESTEP APTT TEST | International Technidyne Corp. | 1992-02-11 | 77 | 0 |
| K913861 | HEMOCHRON(R) KACT | International Technidyne Corp. | 1991-10-18 | 52 | 0 |
| K911997 | TENDERFOOT(R), MODIFICATION | International Technidyne Corp. | 1991-07-17 | 86 | 0 |
| K911995 | PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION | International Technidyne Corp. | 1991-07-17 | 86 | 0 |
| K911994 | HEMOCHRON(R) APTT, MODIFICATION | International Technidyne Corp. | 1991-07-17 | 86 | 0 |
| K911996 | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | International Technidyne Corp. | 1991-07-17 | 86 | 0 |
| K910646 | SUPERSERUM REAGENT (SSR) | International Technidyne Corp. | 1991-05-10 | 86 | 0 |
| K910181 | HITT BY HEMOCHRON(R) | International Technidyne Corp. | 1991-05-10 | 114 | 0 |
| K910105 | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 | International Technidyne Corp. | 1991-02-26 | 54 | 0 |
| K904454 | HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION | International Technidyne Corp. | 1990-12-17 | 91 | 0 |
| K900126 | TT AND HNTT BY HEMOCHRON | International Technidyne Corp. | 1990-02-05 | 27 | 0 |
| K893378 | PROTHROMBIN TIME (PT) BY HEMOCHRON | International Technidyne Corp. | 1989-06-22 | 52 | 0 |
| K883968 | TENDERFOOT | International Technidyne Corp. | 1988-12-01 | 72 | 0 |
| K882480 | HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II | International Technidyne Corp. | 1988-08-30 | 75 | 0 |
| K882481 | HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II | International Technidyne Corp. | 1988-08-30 | 75 | 0 |
| K870831 | PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA | International Technidyne Corp. | 1987-06-01 | 90 | 0 |
| K850542 | SURGICUTT - BLEEDING TIME DEVICE | International Technidyne Corp. | 1985-03-01 | 18 | 0 |
| K832189 | HEMOCHRON THROMBOCHRONOMETER | International Technidyne Corp. | 1983-10-14 | 98 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda