510(k) DEN120014
- Device
- VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
- Applicant
- Nanosphere, Inc.
- 510(k) number
- DEN120014
- Product code
- PAM
- Decision
- Unknown (DENG)
- Decision date
- 2012-06-26
- Date received
- 2012-06-15
- Regulation
- 866.3365
- Classification name
- Gram-Positive Bacteria And Their Resistance Markers
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- MARK DEL VECCHIO
- Address
- 4088 Commercial Ave. Northbrook IL US 60062 60062
FDA Registration Numbers#
- 3010749841
- 3002773840
- 3006028115
- 3008632402
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PAM#
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|---|---|---|---|
| K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | Luminex Corporation | 2025-06-06 |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | Genmark Diagnostics, Incorporated | 2018-12-20 |
| K163390 | iC-GPC Assay TM for use on the iC-SystemTM | Icubate, Inc. | 2017-08-08 |
| K152470 | Great Basin Staph ID/R Blood Culture Panel | Great Basin Scientific, Inc. | 2016-03-25 |
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST | Nanosphere, Inc. | 2012-09-19 |