The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Solana Gbs Assay.
| Device ID | K173250 |
| 510k Number | K173250 |
| Device Name: | Solana GBS Assay |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| 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 | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-10 |
| Decision Date | 2017-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613336440 | K173250 | 000 |