FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUIDEL MOLECULAR RSV + HMPV ASSAY
K Number: K122189
·
Decision Mar 8, 2013
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
5
Applicant Total
93
Review Days
227
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Basic Information
- Device Name
- QUIDEL MOLECULAR RSV + HMPV ASSAY
- K Number
- K122189
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quidel Corp.
- Date Received
- July 24, 2012
- Decision Date
- March 8, 2013
- Product Code
- OEM
- 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 |
|---|---|---|---|
| OEM | Human Metapneumovirus (Hmpv) Rna Assay System | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OEM), ordered by most recent decision date.
Lyra RSV+hMPV Assay
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PRO HMPV+ ASSAY
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PRO HMPV+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
QUIDEL MOLECULAR HMPV ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
PRO HMPV+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Quidel Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K131813 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Sep 6, 2013 | Substantially Equivalent |
| K131728 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Aug 29, 2013 | Substantially Equivalent |
| K130398 | SOFIA(R) RSV FIA | Aug 13, 2013 | Substantially Equivalent |
| K131166 | SOFIA(R) HCG FIA | Aug 2, 2013 | Substantially Equivalent |
| K131606 | SOFIA INFLUENZA A+B FIA | Jul 5, 2013 | Substantially Equivalent |
| K131619 | QUICKVUE INFLUENZA A+B | Jun 28, 2013 | Substantially Equivalent |
| K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Mar 8, 2013 | Substantially Equivalent |
| K113777 | QUIDEL MOLECULAR INFLUENZA A+B | Mar 15, 2012 | Substantially Equivalent |
| K112172 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Dec 22, 2011 | Substantially Equivalent |
| K112490 | QUIDEL MOLECULAR HMPV ASSAY | Dec 15, 2011 | Substantially Equivalent |