The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Probetec Trichomonas Vaginalis (tv) Qx Amplified Dna Assay.
| Device ID | K130268 |
| 510k Number | K130268 |
| Device Name: | BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY |
| Classification | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Emily Howard |
| Correspondent | Emily Howard BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | OUY |
| CFR Regulation Number | 866.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-04 |
| Decision Date | 2013-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904434335 | K130268 | 000 |
| 00382904419257 | K130268 | 000 |
| 00382904419189 | K130268 | 000 |
| 00382904419172 | K130268 | 000 |