FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
K Number: K083117
·
Decision May 28, 2009
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
22
Applicant Total
22
Review Days
218
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
- K Number
- K083117
- 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
- October 22, 2008
- Decision Date
- May 28, 2009
- Product Code
- LKO
- 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 |
|---|---|---|---|
| LKO | Anti-Rnp Antibody, Antigen And Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKO), ordered by most recent decision date.
Maverick RNP Assay and Maverick Diagnostic System
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
FDA 510(k)
FDA Class 2
·Immunology
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006
FDA 510(k)
FDA Class 2
·Immunology
RHIGENE MESACUP-2 TEST RNP, MODEL M7741
FDA 510(k)
FDA Class 2
·Immunology
RHIGENE MESACUP2 TEST- RNP
FDA 510(k)
FDA Class 2
·Immunology
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 |