The following data is part of a premarket notification filed by Magnabiosciences, Llc with the FDA for Mict Tsh.
| Device ID | K110761 |
| 510k Number | K110761 |
| Device Name: | MICT TSH |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | MAGNABIOSCIENCES, LLC 6325 LUSK BLVD San Diego, CA 92121 |
| Contact | James L Wyatt |
| Correspondent | James L Wyatt MAGNABIOSCIENCES, LLC 6325 LUSK BLVD San Diego, CA 92121 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-18 |
| Decision Date | 2012-03-09 |
| Summary: | summary |