The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene Mycoplasma Dna Amplification Assay.
| Device ID | K152800 |
| 510k Number | K152800 |
| Device Name: | Illumigene Mycoplasma DNA Amplification Assay |
| Classification | Mycoplasma Pneumoniae Dna Assay System |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DRIVE Cincinnati, OH 45244 |
| Contact | Stefanie Johns |
| Correspondent | Stefanie Johns MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DRIVE Cincinnati, OH 45244 |
| Product Code | OZX |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2015-10-23 |