FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTA LITE TOXOPLASMA IGG
K Number: K971441
·
Decision Dec 2, 1997
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
138
Review Days
228
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Basic Information
- Device Name
- QUANTA LITE TOXOPLASMA IGG
- K Number
- K971441
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Inova Diagnostics, Inc.
- Date Received
- April 18, 1997
- Decision Date
- December 2, 1997
- 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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