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 | K090827 |
| 510k Number | K090827 |
| 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 |
| Contact | Saba Modjarrad |
| Correspondent | Saba Modjarrad BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 |
| Product Code | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-26 |
| Decision Date | 2009-05-27 |
| Summary: | summary |