510(k) K163390
- Device
- IC-GPC Assay TM For Use On The IC-SystemTM
- Applicant
- ICubate, Inc
- 510(k) number
- K163390
- Product code
- PAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-08
- Date received
- 2016-12-02
- Regulation
- 866.3365
- Classification name
- Gram-positive Bacteria And Their Resistance Markers
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Carter Wells
- Address
- 601 Genome Way Huntsville AL US 35806 35806
FDA Registration Numbers#
- 3010749841
- 3002773840
- 3006028115
- 3008632402
Source Documents#
Other 510(k) Records For Product Code PAM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| DEN120014 | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) | Nanosphere, Inc. | 2012-06-26 |
Legacy Summary#
summary
FDA Review#
Decision Summary