The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Fluorescein Conjug. Fract. Mono. Anti..
| Device ID | K772345 |
| 510k Number | K772345 |
| Device Name: | FLUORESCEIN CONJUG. FRACT. MONO. ANTI. |
| Classification | Fab, Fitc, Antigen, Antiserum, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DCB |
| CFR Regulation Number | 866.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-23 |
| Decision Date | 1978-01-05 |