The following data is part of a premarket notification filed by Becton Dickinson And Company with the FDA for Bd Ctgctv2.
| Device ID | K210585 |
| 510k Number | K210585 |
| Device Name: | BD CTGCTV2 |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Applicant | Becton Dickinson And Company 7 Loveton Circle Sparks, MD 21152 |
| Contact | Sue Werner |
| Correspondent | Jessica Dewyer Becton Dickinson And Company 7 Loveton Circle Sparks, MD 21152 |
| Product Code | QEP |
| Subsequent Product Code | LSL |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | OUY |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-26 |
| Decision Date | 2022-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904439798 | K210585 | 000 |
| 00382904439897 | K210585 | 000 |