SENTECH'S ULAB 1000 CLINICAL CHEM.— 510(k) K841575

Name: FDA 510(k) clearance K841575
Creator: U.S. Food and Drug Administration
Published: 1984-07-06

Substantially Equivalent

Sen Tech Medical Corp.

FDA 510(k) clearance K841575 for SENTECH'S ULAB 1000 CLINICAL CHEM., Substantially Equivalent on 1984-07-06. 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: 1984-04-17
Decision date: 1984-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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