LIAISON PLEX Gram-Positive Blood Culture Assay— 510(k) K243490
Substantially EquivalentLuminex Corporation
FDA 510(k) clearance K243490 for LIAISON PLEX Gram-Positive Blood Culture Assay, Substantially Equivalent on 2025-06-06. Applicant: Luminex Corporation. Device class: 2.
Clearance details
- Applicant
- Luminex Corporation
- Product code
- Code PAM
- Device class
- Class 2
- Regulation
- 21 CFR 866.3365
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northbrook, IL, US
Recent devices under product code PAM
view all- K254194 — QIAstat-Dx BCID GPF Plus AMR Panel
- K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
- K163390 — iC-GPC Assay TM for use on the iC-SystemTM
- K152470 — Great Basin Staph ID/R Blood Culture Panel
- K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
More clearances from Luminex Corporation
view allAdverse events under product code PAM
product code PAM- Death
- 6
- Malfunction
- 598
- Total
- 604
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.