The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Thyroid Uptake System & Atomlab 950 Med. Spectrome.
| Device ID | K932153 |
| 510k Number | K932153 |
| Device Name: | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME |
| Classification | Probe, Uptake, Nuclear |
| Applicant | BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley, NY 11967 |
| Product Code | IZD |
| CFR Regulation Number | 892.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-04 |
| Decision Date | 1993-09-07 |