The following data is part of a premarket notification filed by Becton Dickinson Advanced Diagnostics with the FDA for Qtest(r) Strep.
| Device ID | K935667 |
| 510k Number | K935667 |
| Device Name: | QTEST(R) STREP |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | BECTON DICKINSON ADVANCED DIAGNOSTICS 10 LOVETON CIRCLE Sparks, MD 21152 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith BECTON DICKINSON ADVANCED DIAGNOSTICS 10 LOVETON CIRCLE Sparks, MD 21152 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-26 |
| Decision Date | 1994-04-21 |