NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus +1 more— 510(k) K200825
Substantially EquivalentHycor Biomedical
FDA 510(k) clearance K200825 for NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus +1 more, Substantially Equivalent on 2020-06-26. Applicant: Hycor Biomedical. Device class: 2.
Clearance details
- Device name as filed
- NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense
- 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
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