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 |