The following data is part of a premarket notification filed by M.a. Bioproducts with the FDA for Measelisa Test Kit.
| Device ID | K821762 |
| 510k Number | K821762 |
| Device Name: | MEASELISA TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg |
| Applicant | M.A. BIOPRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LJB |
| CFR Regulation Number | 866.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-15 |
| Decision Date | 1982-07-30 |