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 |