SODIUM REAGENT SET— 510(k) K914039

Substantially Equivalent

Sterling 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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