Tenderfoot
Accriva Diagnostics, Inc.
Accriva Diagnostics, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3002721930 | 2250033 | Accriva Diagnostics, Inc. | 1 | N | 2026-01-01 | 6260 Sequence Drive San Diego CA US 92121 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 177278 | 1006989278 | K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM | JOZ | 1999-12-20 |
| 177278 | 1463189511 | K990449 | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE | JPA | 1999-04-13 |
| 177278 | 1253648619 | K983475 | HEMOCHRON RESPONSE | KQG | 1999-05-03 |
| 177278 | 1008370698 | K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT | GJS | 1998-09-30 |
| 177278 | 1600160810 | K972831 | HEMOCHRON CITRATE APTT | GFO | 1997-11-20 |
| 177278 | 1993889331 | K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | JBP | 1996-08-12 |
| 177278 | 1941950893 | K951485 | AVOXIMETER 4000 | JKS | 1995-11-06 |
| 177278 | 1154843949 | K944691 | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II | GGN | 1995-03-15 |
| 177278 | 1899377714 | K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | JBP | 1994-06-30 |
| 177278 | 1927864131 | K940432 | MICROCOAGULATION PROTHROMBIN TIME TEST | GJS | 1994-05-18 |
| 177278 | 1741820083 | K940401 | JR. MICROCOAGULATION SYSTEM | JPA | 1994-05-11 |
| 177278 | 1554820149 | K923302 | TENDERLETT FINGER | FMK | 1993-01-22 |
| 177278 | 1085727997 | K922075 | AVOXIMETER | DQA | 1992-11-04 |
| 177278 | 1002063236 | K913861 | HEMOCHRON(R) KACT | JBP | 1991-10-18 |
| 177278 | 1902619068 | K911997 | TENDERFOOT(R), MODIFICATION | FMK | 1991-07-17 |
| 177278 | 1909811357 | K910105 | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 | GFT | 1991-02-26 |
| 177278 | 1279241774 | K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST | KFF | 1990-11-29 |
| 177278 | 1351884109 | K883968 | TENDERFOOT | FMK | 1988-12-01 |
| 177278 | 1727927888 | K882481 | HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II | GGN | 1988-08-30 |
| 177278 | 1985674464 | K870831 | PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA | JPA | 1987-06-01 |
| 177278 | 1205621477 | K850542 | SURGICUTT - BLEEDING TIME DEVICE | JCA | 1985-03-01 |
| 177278 | 1951683708 | K223352 | Tenderfoot | FMK | 2023-03-02 |
| 177278 | 1824012961 | K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 | JPA | 2021-12-29 |
| 177278 | 1853726384 | K193041 | Hemochron Signature Elite | JPA | 2019-11-22 |
| 177278 | 1723192576 | K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | JOZ | 2015-07-24 |
| 177278 | 1378305286 | K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | GGN | 2013-07-03 |
| 177278 | 1050832737 | K050016 | HEMOCHRON SIGNATURE ELITE | JPA | 2005-02-10 |
| 177278 | 1507102122 | K042423 | VERIFYNOW-ASPIRIN ASSAY | JOZ | 2004-10-06 |
| 177278 | 1494618264 | K030818 | HEMOCHRON RESPONSE/SYSTEM | JPA | 2003-04-02 |
| 177278 | 1868132217 | K020798 | HEMOCHRON JR. SIGNATURE + | JPA | 2002-03-28 |
| 177278 | 1458730765 | K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | JOZ | 2002-05-16 |
| 177278 | 1942684330 | K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | JOZ | 2001-10-16 |
| 177278 | 1358484522 | K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | KFF | 2001-06-06 |
| 177278 | 1407378233 | ||||
| 177278 | 1982335951 | ||||
| 177278 | 1222281950 | ||||
| 177278 | 1232516950 | ||||
| 177278 | 1293379189 | ||||
| 177278 | 1726999624 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JPA | 8 | 2021-12-29 |
| JOZ | 5 | 2015-07-24 |
| FMK | 4 | 2023-03-02 |
| GGN | 3 | 2013-07-03 |
| JBP | 3 | 1996-08-12 |
| KFF | 2 | 2001-06-06 |
| GJS | 2 | 1998-09-30 |
| KQG | 1 | 1999-05-03 |
| GFO | 1 | 1997-11-20 |
| JKS | 1 | 1995-11-06 |
| DQA | 1 | 1992-11-04 |
| GFT | 1 | 1991-02-26 |
| JCA | 1 | 1985-03-01 |
PMN#
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), DirectCHECK ACT+ Whole Blood Control, Level 1 And Level 2, DirectCHECK ACT-LR Whole Blood Control
Accriva Diagnostics, Inc.
Hemochron Signature Elite
Accriva Diagnostics, Inc.