The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Tsh.
| Device ID | K851980 |
| 510k Number | K851980 |
| Device Name: | ENDAB TSH |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
| Contact | John H Carter |
| Correspondent | John H Carter IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-07 |
| Decision Date | 1985-05-31 |