Emit II Plus Cocaine Metabolite Assay— 510(k) K170293
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K170293 for Emit II Plus Cocaine Metabolite Assay, Substantially Equivalent on 2017-10-25. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code DIO
- Device class
- Class 2
- Regulation
- 21 CFR 862.3250
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code DIO
view all- K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
- K211973 — DRI Cocaine Metabolite Assay
- K191638 — Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
- K181499 — DRI Cocaine Metabolite Assay
- K163570 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
More clearances from Siemens Healthcare Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.