FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
K Number: K032166
·
Decision Oct 21, 2003
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
31
Applicant Total
30
Review Days
97
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Basic Information
- Device Name
- BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
- K Number
- K032166
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3480
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Binax, Inc.
- Date Received
- July 16, 2003
- Decision Date
- October 21, 2003
- Product Code
- GQG
- 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 |
|---|---|---|---|
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | FDA class 1 | Microbiology |
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Other Clearances by Binax, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090301 | BINAXNOW PBP2A TEST, MODEL 890-000 | Apr 14, 2010 | Substantially Equivalent |
| K091766 | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 | Feb 24, 2010 | Substantially Equivalent |
| 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 |