The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma.
| Device ID | K133673 |
| 510k Number | K133673 |
| Device Name: | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA |
| Classification | Bordetella Pertussis Dna Assay System |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 River Hills Dr Cincinnati, OH 45244 |
| Contact | Michelle L Smith |
| Correspondent | Michelle L Smith 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 | 2013-11-29 |
| Decision Date | 2014-03-25 |
| Summary: | summary |