The following data is part of a premarket notification filed by Antibodies Inc. with the FDA for Tsh Ria Kit.
Device ID | K791217 |
510k Number | K791217 |
Device Name: | TSH RIA KIT |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
Applicant | ANTIBODIES INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JLW |
CFR Regulation Number | 862.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-02 |
Decision Date | 1979-09-04 |