FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
GLIADIN ANTIBODIES ELISA
K Number: K973910
·
Decision Feb 17, 1999
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
41
Applicant Total
1
Review Days
491
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Basic Information
- Device Name
- GLIADIN ANTIBODIES ELISA
- K Number
- K973910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5750
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Genesis Diagnostics , Ltd.
- Date Received
- October 14, 1997
- Decision Date
- February 17, 1999
- 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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