The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Tsh Ria.
| Device ID | K842948 |
| 510k Number | K842948 |
| Device Name: | AMERLEX-M TSH RIA |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-26 |
| Decision Date | 1984-09-04 |