The following data is part of a premarket notification filed by Becton, Dickinson, And Company with the FDA for Bd Max Ct/gc/tv, Bd Max Instrument.
| Device ID | K151589 |
| 510k Number | K151589 |
| Device Name: | BD MAX CT/GC/TV, BD MAX INSTRUMENT |
| Classification | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Applicant | BECTON, DICKINSON, AND COMPANY 7 LOVETON CIR. MC:694 Sparks, MD 21152 |
| Contact | Katie Coyle |
| Correspondent | Katie Edwards BECTON, DICKINSON, AND COMPANY 7 LOVETON CIR. MC:694 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 | 2015-06-12 |
| Decision Date | 2016-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904438241 | K151589 | 000 |
| 00382904429706 | K151589 | 000 |
| 30382904434206 | K151589 | 000 |
| 30382904433766 | K151589 | 000 |