SODIUM REAGENT SET— 510(k) K914039
Substantially EquivalentSterling Diagnostics, Inc.
FDA 510(k) clearance K914039 for SODIUM REAGENT SET, Substantially Equivalent on 1991-10-31. Applicant: Sterling Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterling Diagnostics, Inc.
- Product code
- Code CEI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1665
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sterling Heights, MI, US
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