ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY— 510(k) K082759
Substantially EquivalentPhadia US, Inc.
FDA 510(k) clearance K082759 for ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY, Substantially Equivalent on 2009-04-10. Applicant: Phadia US, Inc.. Device class: 2.
Clearance details
- Applicant
- Phadia US, Inc.
- Product code
- Code LKJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
Recent devices under product code LKJ
view allMore 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.