The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene Mycoplasma Direct Dna Amplification Assay, Illumigene Mycoplasma Direct External Controls, Illumipro-10.
| Device ID | K160829 |
| 510k Number | K160829 |
| Device Name: | Illumigene Mycoplasma Direct DNA Amplification Assay, Illumigene Mycoplasma Direct External Controls, Illumipro-10 |
| Classification | Mycoplasma Pneumoniae Dna Assay System |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DRIVE Cincinnati, OH 45244 |
| Contact | Michelle L. Smith |
| Correspondent | Michelle L. Smith MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DRIVE Cincinnati, OH 45244 |
| Product Code | OZX |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-25 |
| Decision Date | 2016-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733102189 | K160829 | 000 |
| 00840733102103 | K160829 | 000 |
| 00840733101281 | K160829 | 000 |
| 00840733101274 | K160829 | 000 |