PLUS CHEM S.C.E. REAGENT— 510(k) K791080
Substantially EquivalentSmithkline Diagnostics, Inc.
FDA 510(k) clearance K791080 for PLUS CHEM S.C.E. REAGENT, Substantially Equivalent on 1979-07-24. Applicant: Smithkline Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Smithkline Diagnostics, Inc.
- Product code
- Code CIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1100
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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More clearances from Smithkline Diagnostics, Inc.
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