Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae— 510(k) K191510
Substantially EquivalentHycor Biomedical
FDA 510(k) clearance K191510 for Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae, Substantially Equivalent on 2019-07-31. Applicant: Hycor Biomedical. Device class: 2.
Clearance details
- Applicant
- Hycor Biomedical
- Product code
- Code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Garden Grove, CA, US
Recent devices under product code DHB
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Data sourced from openFDA. This site is unofficial and independent of the FDA.