LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030— 510(k) K891574

Name: FDA 510(k) clearance K891574
Creator: U.S. Food and Drug Administration
Published: 1989-06-09

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K891574 for LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030, Substantially Equivalent on 1989-06-09. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code JGT
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 1989-03-20
Decision date: 1989-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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