FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOXOPLASMA GONDII IGG ELISA KIT
K Number: K875258
·
Decision Sep 30, 1988
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
2
Review Days
283
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Basic Information
- Device Name
- TOXOPLASMA GONDII IGG ELISA KIT
- K Number
- K875258
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- De Ferris Laboratories, Inc.
- Date Received
- December 22, 1987
- Decision Date
- September 30, 1988
- 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 De Ferris Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880433 | CYTOMEGALOVIRUS IGG EIA KIT | Mar 27, 1989 | Substantially Equivalent |