The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Solana Strep Complete Assay.
| Device ID | K162274 |
| 510k Number | K162274 |
| Device Name: | Solana Strep Complete Assay |
| Classification | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| Applicant | Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 |
| Contact | Ronald H Lollar |
| Correspondent | Ronald H Lollar Quidel Corporation 2005 East State Street, Suite 100 Athens, OH 45701 |
| Product Code | PGX |
| CFR Regulation Number | 866.2680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-12 |
| Decision Date | 2016-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613336136 | K162274 | 000 |