FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
K Number: K070522
·
Decision Mar 15, 2007
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
9
Applicant Total
1
Review Days
20
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Basic Information
- Device Name
- MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
- K Number
- K070522
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inverness Medical Professional Diagnostics
- Date Received
- February 23, 2007
- Decision Date
- March 15, 2007
- Product Code
- MJH
- 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 |
|---|---|---|---|
| MJH | Legionella, Spp., Elisa | FDA class 2 | Microbiology |
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