FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
K Number: K083294
·
Decision Jul 24, 2009
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
11
Applicant Total
16
Review Days
256
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Basic Information
- Device Name
- VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
- K Number
- K083294
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5900
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nanosphere, Inc.
- Date Received
- November 10, 2008
- Decision Date
- July 24, 2009
- Product Code
- NUA
- Advisory Committee
- Immunology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| NUA | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection | FDA class 2 | Immunology |
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Other Clearances by Nanosphere, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | Sep 4, 2015 | Substantially Equivalent |
| K140083 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) | Jun 20, 2014 | Substantially Equivalent |
| K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) | Jan 8, 2014 | Substantially Equivalent |
| K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) | Dec 5, 2012 | Substantially Equivalent |
| K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) | Nov 6, 2012 | Substantially Equivalent |
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST | Sep 19, 2012 | Substantially Equivalent |
| DEN120014 | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) | Jun 26, 2012 | Unknown |
| K112424 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) | Dec 16, 2011 | Substantially Equivalent |
| K103209 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) | Jan 10, 2011 | Substantially Equivalent |
| K093337 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM | Nov 17, 2009 | Substantially Equivalent |