BD MAX MRSA ASSAY, BD MAX INSTRUMENT— 510(k) K120138
Substantially EquivalentBd Diagnostics (Geneohm Sciences Canada, Inc)
FDA 510(k) clearance K120138 for BD MAX MRSA ASSAY, BD MAX INSTRUMENT, Substantially Equivalent on 2012-07-05. Applicant: Bd Diagnostics (Geneohm Sciences Canada, Inc). Device class: 2.
Clearance details
- Applicant
- Bd Diagnostics (Geneohm Sciences Canada, Inc)
- Product code
- Code NQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, MD, US
Recent devices under product code NQX
view allMore clearances from Bd Diagnostics (Geneohm Sciences Canada, Inc)
view allRecalls naming K120138
K-number listed on FDA's recall record- Z-0238-2026 — BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
- Z-0590-2025 — BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
- Z-2328-2019 — Kit BD Max MRSA; Catalog # 442953
- Z-2618-2014 — The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120138.
Data sourced from openFDA. This site is unofficial and independent of the FDA.