FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
K Number: K070804
·
Decision Sep 17, 2007
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
5
Applicant Total
16
Review Days
178
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Basic Information
- Device Name
- VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
- K Number
- K070804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3360
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanosphere, Inc.
- Date Received
- March 23, 2007
- Decision Date
- September 17, 2007
- Product Code
- ODW
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| ODW | Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System | FDA class 2 | Clinical Toxicology |
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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 |