The following data is part of a premarket notification filed by Quidel Corporation with the FDA for Amplivue Bordetella Assay.
| Device ID | K143206 |
| 510k Number | K143206 |
| Device Name: | AmpliVue Bordetella Assay |
| Classification | Bordetella Pertussis Dna Assay 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 | OZZ |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-07 |
| Decision Date | 2014-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613312093 | K143206 | 000 |