SODIUM/POTASSIUM REAGENT SYS— 510(k) K840216

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K840216 for SODIUM/POTASSIUM REAGENT SYS, Substantially Equivalent on 1984-03-19. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code JGT
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 1984-01-19
Decision date: 1984-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.