The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Assay Reagents, Lsa 290.
| Device ID | K790588 |
| 510k Number | K790588 |
| Device Name: | ASSAY REAGENTS, LSA 290 |
| Classification | Tip, Rubber, Oral Hygiene |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JEW |
| CFR Regulation Number | 872.6650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-27 |
| Decision Date | 1979-05-15 |