The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene Pertussis Dna Amplification Assay.
| Device ID | K152285 |
| 510k Number | K152285 |
| Device Name: | Illumigene Pertussis DNA Amplification Assay |
| Classification | Bordetella Pertussis Dna Assay System |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 River Hills Dr Cincinnati, OH 45244 |
| Contact | Susan Rolih |
| Correspondent | Susan Rolih MERIDIAN BIOSCIENCE, INC. 3471 River Hills Dr Cincinnati, OH 45244 |
| Product Code | OZZ |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-12 |
| Decision Date | 2015-11-10 |