The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Culturette Brand Toxin Cd Test.
| Device ID | K925329 |
| 510k Number | K925329 |
| Device Name: | CULTURETTE BRAND TOXIN CD TEST |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 987 Columbus, NE 68602 -0987 |
| Contact | Robert E James |
| Correspondent | Robert E James BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 987 Columbus, NE 68602 -0987 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-21 |
| Decision Date | 1993-03-24 |