The following data is part of a premarket notification filed by American Dade with the FDA for Stratus Procainamide Fluorometric Enzyme Immunoass.
| Device ID | K853548 |
| 510k Number | K853548 |
| Device Name: | STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Karen H Darcy |
| Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1985-09-18 |