The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Sofia (r) Strep A+ Fia.
| Device ID | K141775 |
| 510k Number | K141775 |
| Device Name: | SOFIA (R) STREP A+ FIA |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | QUIDEL CORPORATION 12544 HIGH BLUFF (ADMINISTRATIVE OFFICE LOCATION) San Diego, CA 92130 |
| Contact | John D Tamerius |
| Correspondent | John D Tamerius QUIDEL CORPORATION 12544 HIGH BLUFF (ADMINISTRATIVE OFFICE LOCATION) San Diego, CA 92130 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-01 |
| Decision Date | 2014-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613202769 | K141775 | 000 |
| 30014613202745 | K141775 | 000 |