FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
K Number: K101564
·
Decision Jun 22, 2010
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
17
Review Days
18
Basic Information
- Device Name
- CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
- K Number
- K101564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3332
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CENTERS FOR DISEASE CONTROL AND PREVENTION
- Date Received
- June 4, 2010
- Decision Date
- June 22, 2010
- Product Code
- OQW
- 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 |
|---|---|---|---|
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | FDA class 2 | Microbiology |
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Other Clearances by CENTERS FOR DISEASE CONTROL AND PREVENTION
| K Number | Device Name | ||
|---|---|---|---|
| DEN070001 | NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET | Sep 21, 2018 | Unknown |
| K141859 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING | Aug 1, 2014 | Substantially Equivalent |
| K140851 | INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Apr 25, 2014 | Substantially Equivalent |
| K140857 | INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Apr 25, 2014 | Substantially Equivalent |
| K132508 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Sep 23, 2013 | Substantially Equivalent |
| DEN130005 | QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS | Aug 8, 2013 | Unknown |
| K130551 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | May 22, 2013 | Substantially Equivalent |
| K123905 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Jan 14, 2013 | Substantially Equivalent |
| DEN120012 | CDC DENV-1-4 REAL TIME RT-PCT ASSAY | May 24, 2012 | Unknown |
| K111507 | CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL | Aug 23, 2011 | Substantially Equivalent |