ENCORE CHEMISTRY ANALYZER— 510(k) K830641

Name: FDA 510(k) clearance K830641
Creator: U.S. Food and Drug Administration
Published: 1983-04-05

Substantially Equivalent

Baker Instructions Corp.

FDA 510(k) clearance K830641 for ENCORE CHEMISTRY ANALYZER, Substantially Equivalent on 1983-04-05. Applicant: Baker Instructions Corp.. Device class: 1.

Clearance details

Applicant: Baker Instructions Corp.
Product code: Code JJG
Device class: Class 1
Regulation: 21 CFR 862.2140
Advisory panel: Clinical Chemistry
Date received: 1983-03-01
Decision date: 1983-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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