The following data is part of a premarket notification filed by Burroughs Wellcome Co. with the FDA for Dac-cel Tsh.
Device ID | K810213 |
510k Number | K810213 |
Device Name: | DAC-CEL TSH |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
Applicant | BURROUGHS WELLCOME CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JLW |
CFR Regulation Number | 862.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-27 |
Decision Date | 1981-02-10 |