The following data is part of a premarket notification filed by American Dade with the FDA for Stratus Primidone Florometric Enzy.
| Device ID | K842196 |
| 510k Number | K842196 |
| Device Name: | STRATUS PRIMIDONE FLOROMETRIC ENZY |
| Classification | Fluorescent Immunoassay, Primidone |
| Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFT |
| CFR Regulation Number | 862.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-04 |
| Decision Date | 1984-07-11 |