The following data is part of a premarket notification filed by American Dade with the FDA for Stratus Tsh Fluorometric Enzyme Immunoassay.
| Device ID | K862428 |
| 510k Number | K862428 |
| Device Name: | STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| 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 | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-26 |
| Decision Date | 1986-08-19 |