FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
K Number: K140083
·
Decision Jun 20, 2014
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
37
Applicant Total
16
Review Days
158
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Basic Information
- Device Name
- VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
- K Number
- K140083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3990
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanosphere, Inc.
- Date Received
- January 13, 2014
- Decision Date
- June 20, 2014
- Product Code
- PCH
- 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 |
|---|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | FDA class 2 | Microbiology |
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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 |
| 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 |
| K092957 | VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | Oct 21, 2009 | Substantially Equivalent |