Kallestad Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 92
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K863681 | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM | December 3, 1986 |
| K862917 | PATHFINDER ROTAVIRUS CHEMILUMINESCENT | October 22, 1986 |
| K863682 | PATHFINDER(TM) SPECIMEN COLLECTION KIT | October 10, 1986 |
| K862743 | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS | September 29, 1986 |
| K862313 | KALLESTAD SM/RNP TEST REAGENT | August 6, 1986 |
| K862710 | KALLESTAD SSA/SSB ENA TEST REAGENTS | July 29, 1986 |
| K855014 | QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A | March 14, 1986 |
| K855010 | QUANTIMETRIC PLUS IGM REAGENT KIT | February 28, 1986 |
| K855013 | QUANTIMETRIC PLUS SUPPORT PACK | February 26, 1986 |
| K855009 | QUANTIMETRIC PLUS IGA REAGENT KIT | February 26, 1986 |
| K855012 | QUANTIMETRIC PLUS C4 REAGENT KIT | February 26, 1986 |
| K855011 | QUANTIMETRIC PLUS C3 REAGENT KIT | February 26, 1986 |
| K855007 | QUANTIMETRIC PLUS LAMBDA REAGENT KIT | February 26, 1986 |
| K855008 | QUANTIMETRIC PLUS KAPPA REAGENT KIT | February 26, 1986 |
| K854483 | KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT | December 11, 1985 |
| K853554 | PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS | November 26, 1985 |
| K852999 | QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT | October 21, 1985 |
| K852794 | ALLERCOAT ALLERGEN DISCS | September 19, 1985 |
| K852125 | PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP | July 30, 1985 |
| K852268 | QUANTICLONE IGE RADIOIMMUNASSAY | July 10, 1985 |