FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
CHROMOTITRE E.I.A. TOXOPLASMA IGM
K Number: K872070
·
Decision Oct 20, 1987
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
2
Review Days
144
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Basic Information
- Device Name
- CHROMOTITRE E.I.A. TOXOPLASMA IGM
- K Number
- K872070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Ismunit Istituto Immunologico Intaliano
- Date Received
- May 29, 1987
- Decision Date
- October 20, 1987
- Product Code
- LGD
- 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 |
|---|---|---|---|
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | FDA class 2 | Microbiology |
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Other Clearances by Ismunit Istituto Immunologico Intaliano
| K Number | Device Name | ||
|---|---|---|---|
| K872071 | CHROMOTITRE E.I.A. RUBELLA IGG | Aug 24, 1987 | Substantially Equivalent |