FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
K Number: K033744
·
Decision Jan 20, 2004
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
39
Applicant Total
4
Review Days
50
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Basic Information
- Device Name
- AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
- K Number
- K033744
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hycor Biomedical , Ltd.
- Date Received
- December 1, 2003
- Decision Date
- January 20, 2004
- 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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