The following data is part of a premarket notification filed by Tci New York with the FDA for Tci-31 Lifelong Ovulation Tester.
| Device ID | K013323 |
| 510k Number | K013323 |
| Device Name: | TCI-31 LIFELONG OVULATION TESTER |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | TCI NEW YORK 575 Shirlynn Court Los Altos, CA 94022 |
| Contact | Erika B Ammirati |
| Correspondent | Erika B Ammirati TCI NEW YORK 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-05 |
| Decision Date | 2001-12-05 |
| Summary: | summary |