SGPT REAGENT SET— 510(k) K841059

Substantially Equivalent

Medical Specialties, Inc.

FDA 510(k) clearance K841059 for SGPT REAGENT SET, Substantially Equivalent on 1984-05-01. Applicant: Medical Specialties, Inc.. Device class: 1.

Clearance details

Applicant: Medical Specialties, Inc.
Product code: Code CKD
Device class: Class 1
Regulation: 21 CFR 862.1030
Advisory panel: Clinical Chemistry
Date received: 1984-03-12
Decision date: 1984-05-01
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.