IMMUNOCAP RAPID READER, MODEL 12-3600-10— 510(k) K092978
Substantially EquivalentPhadia US, Inc.
FDA 510(k) clearance K092978 for IMMUNOCAP RAPID READER, MODEL 12-3600-10, Substantially Equivalent on 2010-01-19. Applicant: Phadia US, Inc.. Device class: 2.
Clearance details
- Applicant
- Phadia US, Inc.
- 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
- Portage, MI, US
Recent devices under product code DHB
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- K132631 — EIA SMDP IMMUNOASSAY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.