FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MACRA LP(A) ENZYME IMMUNOASSAY KIT
K Number: K992665
·
Decision Nov 26, 1999
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
42
Applicant Total
11
Review Days
109
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Basic Information
- Device Name
- MACRA LP(A) ENZYME IMMUNOASSAY KIT
- K Number
- K992665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5600
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trinity Biotech USA
- Date Received
- August 9, 1999
- Decision Date
- November 26, 1999
- Product Code
- DFC
- Advisory Committee
- Immunology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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| K033070 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | Nov 26, 2003 | Substantially Equivalent |
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| K033067 | PYLORI IGG | Nov 26, 2003 | Substantially Equivalent |
| K033064 | MYCOPLASMA IGG | Nov 26, 2003 | Substantially Equivalent |
| K033083 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | Nov 26, 2003 | Substantially Equivalent |
| K993839 | ENA PROFILE ELISA TEST SYSTEM | Jan 12, 2000 | Substantially Equivalent |