FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K Number: K033083
·
Decision Nov 26, 2003
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
110
Applicant Total
11
Review Days
58
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Basic Information
- Device Name
- BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- K Number
- K033083
- 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 USA
- Date Received
- September 29, 2003
- Decision Date
- November 26, 2003
- Product Code
- LSR
- 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 |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | FDA class 2 | Microbiology |
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