SPIN-CHEM TRIGLYCERIDES REAGENT— 510(k) K812471
Substantially EquivalentSmithkline Diagnostics, Inc.
FDA 510(k) clearance K812471 for SPIN-CHEM TRIGLYCERIDES REAGENT, Substantially Equivalent on 1981-09-14. Applicant: Smithkline Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Smithkline Diagnostics, Inc.
- Product code
- Code CDT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1705
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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