The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Probetec Neisseria Gonorrhoeae (gc) Qx Amplified Dna Assay.
| Device ID | K140448 |
| 510k Number | K140448 |
| Device Name: | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY |
| Classification | Dna-reagents, Neisseria |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Sherma Winston |
| Correspondent | Sherma Winston BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-21 |
| Decision Date | 2014-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904428426 | K140448 | 000 |