FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
K Number: K093459
·
Decision Aug 13, 2010
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
41
Applicant Total
22
Review Days
280
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Basic Information
- Device Name
- ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
- K Number
- K093459
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5750
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phadia US, Inc.
- Date Received
- November 6, 2009
- Decision Date
- August 13, 2010
- Product Code
- MST
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MST | Antibodies, Gliadin | FDA class 2 | Immunology |
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Other Clearances by Phadia US, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141375 | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | Feb 13, 2015 | Substantially Equivalent |
| K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO | Oct 27, 2014 | Substantially Equivalent |
| K132631 | EIA SMDP IMMUNOASSAY | Aug 29, 2014 | Substantially Equivalent |
| K131821 | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | Dec 23, 2013 | Substantially Equivalent |
| K122197 | AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES | Aug 28, 2013 | Substantially Equivalent |
| K113841 | IMMUNOCAP ALLERGEN COMPONENTS BUNDLE | Sep 13, 2012 | Substantially Equivalent |
| K112414 | ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY | Jun 22, 2012 | Substantially Equivalent |
| DEN120001 | IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE | Feb 15, 2012 | Unknown |
| K111919 | IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS | Dec 22, 2011 | Substantially Equivalent |
| K102673 | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM | Sep 30, 2011 | Substantially Equivalent |