FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Architect CMV IgG
K Number: K220949
·
Decision Oct 27, 2022
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
57
Applicant Total
883
Review Days
209
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Basic Information
- Device Name
- Architect CMV IgG
- K Number
- K220949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- April 1, 2022
- Decision Date
- October 27, 2022
- 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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