The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Probe Tec Urine Preservative Transport.
| Device ID | K052224 |
| 510k Number | K052224 |
| Device Name: | BD PROBE TEC URINE PRESERVATIVE TRANSPORT |
| Classification | Dna-reagents, Neisseria |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Kathryn Babka Powers |
| Correspondent | Kathryn Babka Powers 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 | 2005-08-16 |
| Decision Date | 2005-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382904409280 | K052224 | 000 |