FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APL IGA ELISA KIT
K Number: K021398
·
Decision Aug 27, 2002
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
93
Applicant Total
3
Review Days
117
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Basic Information
- Device Name
- APL IGA ELISA KIT
- K Number
- K021398
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Louisville Apl Diagnostics, Inc.
- Date Received
- May 2, 2002
- Decision Date
- August 27, 2002
- Product Code
- MID
- 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 |
|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | FDA class 2 | Immunology |
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