ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
FDA 510(k) clearance K133673 · decided 2014-03-25
Clearance details
- K-number
- K133673
- Device name
- ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-29
- Decision date
- 2014-03-25
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- OZZ
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.