FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPUS(R) ANTI CMV-M
K Number: K913080
·
Decision Oct 28, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
17
Applicant Total
4
Review Days
109
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Basic Information
- Device Name
- OPUS(R) ANTI CMV-M
- K Number
- K913080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3175
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pb Diagnostics, Inc.
- Date Received
- July 11, 1991
- Decision Date
- October 28, 1991
- Product Code
- LKQ
- 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 |
|---|---|---|---|
| LKQ | Antibody Igm,If, Cytomegalovirus Virus | FDA class 2 | Microbiology |
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