SYSTEMATE CALCIUM TEST TECHNICON RA 1000— 510(k) K922953

Name: FDA 510(k) clearance K922953
Creator: U.S. Food and Drug Administration
Published: 1992-09-09

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K922953 for SYSTEMATE CALCIUM TEST TECHNICON RA 1000, Substantially Equivalent on 1992-09-09. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CIL
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1992-06-18
Decision date: 1992-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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