FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
K Number: K071692
·
Decision Nov 5, 2007
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
39
Applicant Total
22
Review Days
138
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Basic Information
- Device Name
- THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
- K Number
- K071692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theratest Laboratories, Inc.
- Date Received
- June 20, 2007
- Decision Date
- November 5, 2007
- Product Code
- MVM
- 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 |
|---|---|---|---|
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | FDA class 2 | Immunology |
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Other Clearances by Theratest Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090753 | THERATEST EL-ANTI-CCP/2 | Mar 5, 2010 | Substantially Equivalent |
| K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 | Sep 3, 2009 | Substantially Equivalent |
| K061376 | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 | Jul 20, 2006 | Substantially Equivalent |
| K060176 | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA | Feb 7, 2006 | Substantially Equivalent |
| K051066 | THERATEST EL-ANA PROFILES | Oct 7, 2005 | Substantially Equivalent |
| K040291 | EL-ANA PROFILES: ANTI-CHROMATIN | Mar 11, 2004 | Substantially Equivalent |
| K024031 | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE | Feb 6, 2003 | Substantially Equivalent |
| K024151 | EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P | Feb 6, 2003 | Substantially Equivalent |
| K002559 | EL-ANA PROFILES-2K1 | Sep 12, 2000 | Substantially Equivalent |
| K982622 | EL-ANA PROFILES: EL-ENA/5 | Aug 13, 1998 | Substantially Equivalent |