FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYCOPLASMA IGG
K Number: K033064
·
Decision Nov 26, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
288
Applicant Total
11
Review Days
58
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Basic Information
- Device Name
- MYCOPLASMA IGG
- K Number
- K033064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1645
- 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
- LON
- 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 |
|---|---|---|---|
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | FDA class 2 | Microbiology |
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|---|---|---|---|
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| K033070 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | Nov 26, 2003 | Substantially Equivalent |
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| K033079 | CHLAMYDIA IGG ELISA TEST SYSTEM | Nov 26, 2003 | Substantially Equivalent |
| K033067 | PYLORI 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 |