ePlex Respiratory Pathogen Panel— 510(k) K163636
Substantially EquivalentGenmark Diagnostics, Incorporated
FDA 510(k) clearance K163636 for ePlex Respiratory Pathogen Panel, Substantially Equivalent on 2017-06-09. Applicant: Genmark Diagnostics, Incorporated. Device class: 2.
Clearance details
- Applicant
- Genmark Diagnostics, Incorporated
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code OCC
view allMore clearances from Genmark Diagnostics, Incorporated
view all- K213236 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
- K182619 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
- K182690 — ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
- K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
- K163652 — ePlex Instrument
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.