FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT
K Number: K885344
·
Decision Apr 12, 1989
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
3
Review Days
105
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Basic Information
- Device Name
- IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT
- K Number
- K885344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Orgenics, Ltd.
- Date Received
- December 28, 1988
- Decision Date
- April 12, 1989
- 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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