The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Hemopexin Nephelometric Assays.
| Device ID | K780250 |
| 510k Number | K780250 |
| Device Name: | HEMOPEXIN NEPHELOMETRIC ASSAYS |
| Classification | Hemopexin, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CZX |
| CFR Regulation Number | 866.5490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-14 |
| Decision Date | 1978-02-28 |