The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad's Endoplate Factor B Test.
| Device ID | K811740 |
| 510k Number | K811740 |
| Device Name: | KALLESTAD'S ENDOPLATE FACTOR B TEST |
| Classification | Factor B, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JZH |
| CFR Regulation Number | 866.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-19 |
| Decision Date | 1981-07-16 |