The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric Plus Igm Reagent Kit.
| Device ID | K855010 |
| 510k Number | K855010 |
| Device Name: | QUANTIMETRIC PLUS IGM REAGENT KIT |
| Classification | Igm, Antigen, Antiserum, Control |
| 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 | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-16 |
| Decision Date | 1986-02-28 |