The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Tsh.
| Device ID | K983442 |
| 510k Number | K983442 |
| Device Name: | ABBOTT ARCHITECT TSH |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | ABBOTT LABORATORIES 100/200 ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | April Veoukas |
| Correspondent | April Veoukas ABBOTT LABORATORIES 100/200 ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | JLW |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-30 |
| Decision Date | 1998-11-20 |
| Summary: | summary |