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GEM Premier 7000 with IQM3

Instrumentation Laboratory Company · Class II · Cleared Aug 10, 2023

K-numberK223608
Device nameGEM Premier 7000 with IQM3
ApplicantInstrumentation Laboratory Company
Product codeCHL
Device classClass II
Decision dateAug 10, 2023
DecisionSubstantially Equivalent
Regulation862.1120
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Source

View the full FDA submission: accessdata.fda.gov

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