FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYTOMEGALOVIRUS IGG EIA KIT
K Number: K880433
·
Decision Mar 27, 1989
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
57
Applicant Total
2
Review Days
420
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Basic Information
- Device Name
- CYTOMEGALOVIRUS IGG EIA KIT
- K Number
- K880433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- De Ferris Laboratories, Inc.
- Date Received
- February 1, 1988
- Decision Date
- March 27, 1989
- 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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Other Clearances by De Ferris Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K875258 | TOXOPLASMA GONDII IGG ELISA KIT | Sep 30, 1988 | Substantially Equivalent |