The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric 2 Ceruloplasmin Assay.
| Device ID | K823107 |
| 510k Number | K823107 |
| Device Name: | QUANTIMETRIC 2 CERULOPLASMIN ASSAY |
| Classification | Ceruloplasmin, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DDB |
| CFR Regulation Number | 866.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-21 |
| Decision Date | 1982-11-16 |