FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K Number: K001525
·
Decision Nov 29, 2000
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
34
Applicant Total
5
Review Days
197
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Basic Information
- Device Name
- CAPTIA SYPHILIS-G ELISA TEST SYSTEM
- K Number
- K001525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3830
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trinity Biotech, Plc
- Date Received
- May 16, 2000
- Decision Date
- November 29, 2000
- Product Code
- LIP
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | FDA class 2 | Microbiology |
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