The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric Tm 2 Kappa & Lambda Kit.
| Device ID | K841864 |
| 510k Number | K841864 |
| Device Name: | QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT |
| Classification | Lambda, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DEH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-04 |
| Decision Date | 1984-07-11 |