ARTUS C. DIFFICILE QS-RGQ MDX KIT— 510(k) K133936
Substantially EquivalentQIAGEN GmbH
FDA 510(k) clearance K133936 for ARTUS C. DIFFICILE QS-RGQ MDX KIT, Substantially Equivalent on 2014-04-04. Applicant: QIAGEN GmbH. Device class: 2.
Clearance details
- Applicant
- QIAGEN GmbH
- Product code
- Code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gaithersburg, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.