The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Max Ctgctv2, Bd Max System.
| Device ID | K182692 |
| 510k Number | K182692 |
| Device Name: | BD MAX CTGCTV2, BD MAX System |
| Classification | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Applicant | Becton, Dickinson And Company 7 Loveton Circle Sparks, MD 21152 |
| Contact | Katie Edwards |
| Correspondent | Katie Edwards Becton, Dickinson And Company 7 Loveton Circle Sparks, MD 21152 |
| Product Code | OUY |
| Subsequent Product Code | LSL |
| Subsequent Product Code | MKZ |
| CFR Regulation Number | 866.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2019-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904439040 | K182692 | 000 |
| 00382904439231 | K182692 | 000 |
| 00382904402969 | K182692 | 000 |
| 00382904439248 | K182692 | 000 |