ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01— 510(k) K062583
Substantially EquivalentPhadia US, Inc.
FDA 510(k) clearance K062583 for ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01, Substantially Equivalent on 2006-12-26. Applicant: Phadia US, Inc.. Device class: 2.
Clearance details
- Applicant
- Phadia US, Inc.
- Product code
- Product code MVM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
Recent devices under product code MVM
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More clearances from Phadia US, Inc.
view all- K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
- K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
- K132631 — EIA SMDP IMMUNOASSAY
- K131821 — ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
- K122197 — AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.