The following data is part of a premarket notification filed by M.a. Bioproducts with the FDA for Cytomegelisa Stat.
| Device ID | K830615 |
| 510k Number | K830615 |
| Device Name: | CYTOMEGELISA STAT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | M.A. BIOPRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-28 |
| Decision Date | 1983-05-09 |