FDA Product Code
FDA Product Code PAM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3365
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254194 | QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH | 2026-08-06 | Traditional | PDF ↗ |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture Assay | Luminex Corporation | 2025-06-06 | Traditional | PDF ↗ |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | Genmark Diagnostics, Incorporated | 2018-12-20 | Traditional | PDF ↗ |
| K163390 | iC-GPC Assay TM for use on the iC-SystemTM | Icubate, Inc. | 2017-08-08 | Traditional | PDF ↗ |
| K152470 | Great Basin Staph ID/R Blood Culture Panel | Great Basin Scientific, Inc. | 2016-03-25 | Traditional | PDF ↗ |
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST | Nanosphere, Inc. | 2012-09-19 | Traditional | PDF ↗ |
| DEN120014 | VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) | Nanosphere, Inc. | 2012-06-26 | Post-NSE | — |
Product code PAM · Class II · Microbiology. Data: openFDA.