510(k) K152800
- Device
- Illumigene Mycoplasma DNA Amplification Assay
- Applicant
- MERIDIAN BIOSCIENCE, INC.
- 510(k) number
- K152800
- Product code
- OZX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-10-23
- Date received
- 2015-09-28
- Regulation
- 866.3980
- Classification name
- Mycoplasma Pneumoniae Dna Assay System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stefanie Johns
- Address
- 3471 River Hills Dr. Cincinnati OH US 45244 45244
FDA Registration Numbers#
- 3013019728
- 3003030793
- 3010770794
- 3010749841
- 3002777243
- 3007799234
- 3006028115
- 3038610665
- 1524213
- 3006198300
- 3002773840
- 3008632402
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OZX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 | Meridian Bioscience, Inc. | 2016-06-13 |
| K123423 | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT | Meridian Bioscience, Inc. | 2013-06-05 |
Legacy Summary#
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FDA Review#
Decision Summary