The following data is part of a premarket notification filed by Bio Nuclear Diagnostics, Inc. with the FDA for Bio Nuclear Diagnostics (endo)cervical Sampler For Gyn Cytology.
| Device ID | K081522 |
| 510k Number | K081522 |
| Device Name: | BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY |
| Classification | Spatula, Cervical, Cytological |
| Applicant | BIO NUCLEAR DIAGNOSTICS, INC. 1791 ALBION RD. Toronto, Ontario, CA M9w 5s7 |
| Contact | Surender Choudhry |
| Correspondent | Surender Choudhry BIO NUCLEAR DIAGNOSTICS, INC. 1791 ALBION RD. Toronto, Ontario, CA M9w 5s7 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-30 |
| Decision Date | 2008-12-05 |