SKD ELECTROCHEMICAL SYSTEM (ECS)— 510(k) K854723
Substantially EquivalentSmithkline Diagnostics, Inc.
FDA 510(k) clearance K854723 for SKD ELECTROCHEMICAL SYSTEM (ECS), Substantially Equivalent on 1986-03-05. Applicant: Smithkline Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Smithkline Diagnostics, Inc.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code CEM
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