The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Imx Ultrasentitive Htsh.
| Device ID | K902753 |
| 510k Number | K902753 |
| Device Name: | IMX ULTRASENTITIVE HTSH |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | ABBOTT MFG., INC. Abbott Park, IL 60064 |
| Contact | Carolyn Bairstow |
| Correspondent | Carolyn Bairstow ABBOTT MFG., INC. Abbott Park, IL 60064 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-22 |
| Decision Date | 1990-07-10 |