Kallestad Laboratories, Inc.
FDA 510(k) & PMA Approved Devices — 92 products
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Total Devices92
Categories0
Latest FDA decision
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K863681 | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM | LJP | 1986-12-03 | View |
| 510(k) | K862917 | PATHFINDER ROTAVIRUS CHEMILUMINESCENT | LIQ | 1986-10-22 | View |
| 510(k) | K863682 | PATHFINDER(TM) SPECIMEN COLLECTION KIT | JSM | 1986-10-10 | View |
| 510(k) | K862743 | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS | GQG | 1986-09-29 | View |
| 510(k) | K862313 | KALLESTAD SM/RNP TEST REAGENT | LKJ | 1986-08-06 | View |
| 510(k) | K862710 | KALLESTAD SSA/SSB ENA TEST REAGENTS | LLL | 1986-07-29 | View |
| 510(k) | K855014 | QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A | JIX | 1986-03-14 | View |
| 510(k) | K855010 | QUANTIMETRIC PLUS IGM REAGENT KIT | DFT | 1986-02-28 | View |
| 510(k) | K855009 | QUANTIMETRIC PLUS IGA REAGENT KIT | CZP | 1986-02-26 | View |
| 510(k) | K855007 | QUANTIMETRIC PLUS LAMBDA REAGENT KIT | DEH | 1986-02-26 | View |
| 510(k) | K855012 | QUANTIMETRIC PLUS C4 REAGENT KIT | DBI | 1986-02-26 | View |
| 510(k) | K855013 | QUANTIMETRIC PLUS SUPPORT PACK | DEH | 1986-02-26 | View |
| 510(k) | K855011 | QUANTIMETRIC PLUS C3 REAGENT KIT | CZN | 1986-02-26 | View |
| 510(k) | K855008 | QUANTIMETRIC PLUS KAPPA REAGENT KIT | DFH | 1986-02-26 | View |
| 510(k) | K854483 | KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT | KTO | 1985-12-11 | View |
| 510(k) | K853554 | PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS | LIQ | 1985-11-26 | View |
| 510(k) | K852999 | QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT | DEH | 1985-10-21 | View |
| 510(k) | K852794 | ALLERCOAT ALLERGEN DISCS | DHB | 1985-09-19 | View |
| 510(k) | K852125 | PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP | GQL | 1985-07-30 | View |
| 510(k) | K852268 | QUANTICLONE IGE RADIOIMMUNASSAY | DGC | 1985-07-10 | View |
No matching devices.
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