The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Tsh-ctk-3 Irma.
| Device ID | K041014 |
| 510k Number | K041014 |
| Device Name: | TSH-CTK-3 IRMA |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| Contact | David M Ikeda |
| Correspondent | David M Ikeda DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 Stillwater, MN 55082 |
| 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 | 2004-04-20 |
| Decision Date | 2004-07-14 |
| Summary: | summary |