CHEM PRO 1000 CHEMISTRY ANALYSIS— 510(k) K851100

Name: FDA 510(k) clearance K851100
Creator: U.S. Food and Drug Administration
Published: 1985-07-09

Substantially Equivalent

Sen Tech Medical Corp.

FDA 510(k) clearance K851100 for CHEM PRO 1000 CHEMISTRY ANALYSIS, Substantially Equivalent on 1985-07-09. Applicant: Sen Tech Medical Corp.. Device class: 2.

Clearance details

Applicant: Sen Tech Medical Corp.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1985-03-19
Decision date: 1985-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, MN, US

Download summary PDF View on FDA.gov ↗

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