The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene Mycoplasama Dna Amplification Assay, And Illumigene Mycoplasma External Controls Kit.
| Device ID | K123423 |
| 510k Number | K123423 |
| Device Name: | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT |
| 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 | 2012-11-06 |
| Decision Date | 2013-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101175 | K123423 | 000 |