The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Probetec Neisseria Gonorrhoeae (gc) Q Amplified Dna Assay.
| Device ID | K081825 |
| 510k Number | K081825 |
| Device Name: | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY |
| Classification | Dna-reagents, Neisseria |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Kathryn B Carr |
| Correspondent | Kathryn B Carr 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 | 2008-06-27 |
| Decision Date | 2008-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904411282 | K081825 | 000 |
| 00382904411251 | K081825 | 000 |
| 30382904411221 | K081825 | 000 |
| 30382904413621 | K081825 | 000 |
| 30382904413614 | K081825 | 000 |
| 30382904413584 | K081825 | 000 |
| 30382904413577 | K081825 | 000 |
| 30382904411290 | K081825 | 000 |
| 00382904411244 | K081825 | 000 |