The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kappa & Lambda Bence Jones Controls.
| Device ID | K812327 |
| 510k Number | K812327 |
| Device Name: | KAPPA & LAMBDA BENCE JONES CONTROLS |
| Classification | Bence-jones Protein, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CZQ |
| CFR Regulation Number | 866.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-18 |
| Decision Date | 1981-09-01 |