FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
K Number: K082759
·
Decision Apr 10, 2009
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
49
Applicant Total
22
Review Days
200
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Basic Information
- Device Name
- ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY
- K Number
- K082759
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phadia US, Inc.
- Date Received
- September 22, 2008
- Decision Date
- April 10, 2009
- Product Code
- LKJ
- 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 |
|---|---|---|---|
| LKJ | Antinuclear Antibody, Antigen, Control | 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 |