POTASSIUM TEST— 510(k) K863486

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K863486 for POTASSIUM TEST, Substantially Equivalent on 1986-09-29. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code CEJ
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1986-09-09
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, 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.