EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay— 510(k) K173792
Substantially EquivalentPhadia AB
FDA 510(k) clearance K173792 for EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay, Substantially Equivalent on 2018-03-13. Applicant: Phadia AB. Device class: 2.
Clearance details
- Applicant
- Phadia AB
- Product code
- Code MOB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Recent devices under product code MOB
view all- K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM
- K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
- K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern
- K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
- K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
More clearances from Phadia AB
view all- K253367 — EliA CTD 13 Screen
- K212181 — ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
- K210902 — EliA Ro52, EliA Ro60
- K202540 — EliA Rib-P
- K202541 — EliA RNA Pol III
Recalls naming K173792
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173792.
Data sourced from openFDA. This site is unofficial and independent of the FDA.