CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS— 510(k) K855091

Name: FDA 510(k) clearance K855091
Creator: U.S. Food and Drug Administration
Published: 1986-03-14

Substantially Equivalent

Sen Tech Medical Corp.

FDA 510(k) clearance K855091 for CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS, Substantially Equivalent on 1986-03-14. Applicant: Sen Tech Medical Corp.. Device class: 2.

Clearance details

Applicant: Sen Tech Medical Corp.
Product code: Code CDS
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1985-12-20
Decision date: 1986-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, MN, US

Download summary PDF View on FDA.gov ↗

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