FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUICKVUE DIPSTICK STREP A
K Number: K011097
·
Decision May 8, 2001
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
43
Applicant Total
93
Review Days
27
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Basic Information
- Device Name
- QUICKVUE DIPSTICK STREP A
- K Number
- K011097
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quidel Corp.
- Date Received
- April 11, 2001
- Decision Date
- May 8, 2001
- Product Code
- GTY
- 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 |
|---|---|---|---|
| GTY | Antigens, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
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| K122189 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Mar 8, 2013 | Substantially Equivalent |
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| K113777 | QUIDEL MOLECULAR INFLUENZA A+B | Mar 15, 2012 | Substantially Equivalent |
| K112172 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Dec 22, 2011 | Substantially Equivalent |