FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
YBBOTT CMV TOTAL AB EIA
K Number: K832221
·
Decision Oct 27, 1983
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
57
Applicant Total
857
Review Days
111
Basic Information
- Device Name
- YBBOTT CMV TOTAL AB EIA
- K Number
- K832221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- ABBOTT LABORATORIES
- Date Received
- July 8, 1983
- Decision Date
- October 27, 1983
- 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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