ELIA GLIADIN IGA, IGG AND CELIAC CONTROL— 510(k) K063775
Substantially EquivalentPhadia US, Inc.
FDA 510(k) clearance K063775 for ELIA GLIADIN IGA, IGG AND CELIAC CONTROL, Substantially Equivalent on 2007-03-14. Applicant: Phadia US, Inc.. Device class: 2.
Clearance details
- Applicant
- Phadia US, Inc.
- Product code
- Code MST
- 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 MST
view all- K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA
- K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
- K113377 — GLIADIN IGA AND GLIADIN LGA
- K113863 — QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
- K111414 — QUANTA FLASH (TM) DGP SCREEN
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.