The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Biodex Act-o-kit Tsh-ria-.
| Device ID | K840088 |
| 510k Number | K840088 |
| Device Name: | BIODEX ACT-O-KIT TSH-RIA- |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | BIODAN MEDICAL SYSTEMS, LTD. P.O.B. 2012 REHOVOT 76120 Israel, IL |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-10 |
| Decision Date | 1984-05-07 |