FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
K Number: K033105
·
Decision Jul 13, 2004
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
11
Review Days
287
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Basic Information
- Device Name
- CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT
- K Number
- K033105
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trinity Biotech USA
- Date Received
- September 30, 2003
- Decision Date
- July 13, 2004
- Product Code
- MXJ
- 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 |
|---|---|---|---|
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | FDA class 2 | Microbiology |
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HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
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Other Clearances by Trinity Biotech USA
| K Number | Device Name | ||
|---|---|---|---|
| K140455 | CAPTIA MEASLES IGM | May 22, 2014 | Substantially Equivalent |
| K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | Jul 13, 2004 | Substantially Equivalent |
| K033070 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | Nov 26, 2003 | Substantially Equivalent |
| K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM | Nov 26, 2003 | Substantially Equivalent |
| K033079 | CHLAMYDIA IGG ELISA TEST SYSTEM | Nov 26, 2003 | Substantially Equivalent |
| 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 |
| K992665 | MACRA LP(A) ENZYME IMMUNOASSAY KIT | Nov 26, 1999 | Substantially Equivalent |