The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric 2 Test Kit.
| Device ID | K813242 |
| 510k Number | K813242 |
| Device Name: | QUANTIMETRIC 2 TEST KIT |
| Classification | Slides, Microscope |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KEW |
| CFR Regulation Number | 864.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-17 |
| Decision Date | 1981-12-02 |