The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Immunoglobulin M Nephel. Assay.
| Device ID | K772254 |
| 510k Number | K772254 |
| Device Name: | IMMUNOGLOBULIN M NEPHEL. ASSAY |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DFT |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-09 |
| Decision Date | 1977-12-22 |