The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Viper System.
| Device ID | K052481 |
| 510k Number | K052481 |
| Device Name: | BD VIPER SYSTEM |
| Classification | Dna-reagents, Neisseria |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Colleen A Kistler |
| Correspondent | Colleen A Kistler BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-09 |
| Decision Date | 2005-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904428433 | K052481 | 000 |
| 00382904410919 | K052481 | 000 |
| 30382904413546 | K052481 | 000 |