FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
K Number: K982238
·
Decision Aug 21, 1998
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
9
Applicant Total
30
Review Days
57
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Basic Information
- Device Name
- BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
- K Number
- K982238
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Binax, Inc.
- Date Received
- June 25, 1998
- Decision Date
- August 21, 1998
- 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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SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
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MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
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FDA Class 2
·Microbiology
LEGIONELLA PNEUMOPHILA IGG/IGM
FDA 510(k)
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| K080003 | BINAXNOW G6PD TEST | Oct 23, 2008 | Substantially Equivalent |
| K062109 | BINAXNOW INFLUENZA A & B TEST | Nov 9, 2006 | Substantially Equivalent |
| K053126 | BINAXNOW INFLUENZA A & B TEST | Nov 30, 2005 | Substantially Equivalent |
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