FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
K Number: K001393
·
Decision Jun 7, 2000
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
41
Applicant Total
135
Review Days
35
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Basic Information
- Device Name
- THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
- K Number
- K001393
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5750
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Zeus Scientific, Inc.
- Date Received
- May 3, 2000
- Decision Date
- June 7, 2000
- 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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