FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
DIATECH IGM-MP TEST
K Number: K895276
·
Decision Dec 18, 1989
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
12
Applicant Total
3
Review Days
117
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Basic Information
- Device Name
- DIATECH IGM-MP TEST
- K Number
- K895276
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3375
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Diatech Diagnostica , Ltd.
- Date Received
- August 23, 1989
- Decision Date
- December 18, 1989
- Product Code
- LJZ
- 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 |
|---|---|---|---|
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | FDA class 1 | Microbiology |
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