FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST
K Number: K070597
·
Decision Oct 11, 2007
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
12
Applicant Total
16
Review Days
223
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Basic Information
- Device Name
- VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST
- K Number
- K070597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanosphere, Inc.
- Date Received
- March 2, 2007
- Decision Date
- October 11, 2007
- Product Code
- NSU
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| 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 |