The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Directigen 1-2-3 Group A Strep Test.
| Device ID | K951542 |
| 510k Number | K951542 |
| Device Name: | DIRECTIGEN 1-2-3 GROUP A STREP TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 987 Columbus, NE 68602 -0987 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC P.O. BOX 987 Columbus, NE 68602 -0987 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-03 |
| Decision Date | 1995-10-20 |