ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA— 510(k) K133673
Substantially EquivalentMeridian Bioscience, Inc.
FDA 510(k) clearance K133673 for ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA, Substantially Equivalent on 2014-03-25. Applicant: Meridian Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Meridian Bioscience, Inc.
- Product code
- Code OZZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code OZZ
view all- K243753 — cobas liat Bordetella panel nucleic acid test
- K183223 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- K173498 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- K181029 — Solana Bordetella Complete Assay
- K163626 — ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
More clearances from Meridian Bioscience, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.