The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Qvantimetric 2kappa And Lambda Test Kit.
| Device ID | K852999 |
| 510k Number | K852999 |
| Device Name: | QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Susan Retka |
| Correspondent | Susan Retka KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-15 |
| Decision Date | 1985-10-21 |