FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CMV IGM ELISA TEST SYSTEM
K Number: K896355
·
Decision Feb 27, 1990
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
57
Applicant Total
135
Review Days
113
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Basic Information
- Device Name
- CMV IGM ELISA TEST SYSTEM
- K Number
- K896355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Zeus Scientific, Inc.
- Date Received
- November 6, 1989
- Decision Date
- February 27, 1990
- Product Code
- LFZ
- 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 |
|---|---|---|---|
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | FDA class 2 | Microbiology |
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