SKI 5000— 510(k) K812646
Substantially EquivalentSmithkline Diagnostics, Inc.
FDA 510(k) clearance K812646 for SKI 5000, Substantially Equivalent on 1981-11-16. Applicant: Smithkline Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Smithkline Diagnostics, Inc.
- Product code
- Code DXK
- Device class
- Class 2
- Regulation
- 21 CFR 870.2330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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