The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric Plus Calibrator/control Set A.
| Device ID | K855014 |
| 510k Number | K855014 |
| Device Name: | QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Quinlan Smith |
| Correspondent | Quinlan Smith KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-16 |
| Decision Date | 1986-03-14 |