GENESYS GAMMA COUNTER— 510(k) K851689

Name: FDA 510(k) clearance K851689
Creator: U.S. Food and Drug Administration
Published: 1985-08-07

Substantially Equivalent

Laboratory Technologies, Inc.

FDA 510(k) clearance K851689 for GENESYS GAMMA COUNTER, Substantially Equivalent on 1985-08-07. Applicant: Laboratory Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Laboratory Technologies, Inc.
Product code: Code JJJ
Device class: Class 1
Regulation: 21 CFR 862.2320
Advisory panel: Clinical Chemistry
Date received: 1985-04-26
Decision date: 1985-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elburn, IL, US

Download summary PDF View on FDA.gov ↗

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