The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Directigen Neisseria Meningitidis Test.
| Device ID | K920274 |
| 510k Number | K920274 |
| Device Name: | DIRECTIGEN NEISSERIA MENINGITIDIS TEST |
| Classification | Antisera, Fluorescent, All Groups, N. Meningitidis |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Contact | Robert E James |
| Correspondent | Robert E James BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Product Code | GTI |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-22 |
| Decision Date | 1992-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902501602 | K920274 | 000 |