The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Amplivue Gas Assay.
| Device ID | K141173 |
| 510k Number | K141173 |
| Device Name: | AMPLIVUE GAS ASSAY |
| Classification | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| Applicant | QUIDEL CORPORATION 2005 E State St Suite 100 Athens, OH 45701 |
| Contact | Ronald H Lollar |
| Correspondent | Ronald H Lollar QUIDEL CORPORATION 2005 E State St 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 | 2014-05-06 |
| Decision Date | 2014-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613312123 | K141173 | 000 |