FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BINAX LEGIONELLA URINARY ANTIGEN EIA
K Number: K934965
·
Decision Sep 20, 1994
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
9
Applicant Total
30
Review Days
340
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Basic Information
- Device Name
- BINAX LEGIONELLA URINARY ANTIGEN EIA
- K Number
- K934965
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3300
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Binax, Inc.
- Date Received
- October 15, 1993
- Decision Date
- September 20, 1994
- 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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MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
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|---|---|---|---|
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| K090964 | BINAXNOX STAPHYLOCOCCUS AUREUS TEST | Dec 16, 2009 | Substantially Equivalent |
| K091489 | CLEARVIEW ADVANCED STREP A , MODEL 737-430 | Sep 4, 2009 | Substantially Equivalent |
| K083744 | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 | Sep 1, 2009 | Substantially Equivalent |
| K092223 | MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST | Aug 12, 2009 | Substantially Equivalent |
| 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 |
| K041049 | BINAXNOW INFLUENZA A & B TEST | Aug 10, 2004 | Substantially Equivalent |