The following data is part of a premarket notification filed by Atomic Products Corp. with the FDA for Thyroid Uptake Syst/automlab 900 Medi Spec 187-900.
| Device ID | K913055 |
| 510k Number | K913055 |
| Device Name: | THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 |
| Classification | Probe, Uptake, Nuclear |
| Applicant | ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein ATOMIC PRODUCTS CORP. P.O. DRAWER R 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 | 1991-07-09 |
| Decision Date | 1991-09-06 |