GENESIS RMP

K963268 · Tecan U.S., Inc. · JRA · Mar 18, 1997 · Clinical Chemistry

Device Facts

Record IDK963268
Device NameGENESIS RMP
ApplicantTecan U.S., Inc.
Product CodeJRA · Clinical Chemistry
Decision DateMar 18, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 862.2680
Device ClassClass 1

Regulatory Classification

Identification

A microtitrator for clinical use is a device intended for use in micronanalysis to measure the concentration of a substance by reacting it with a measure “micro” volume of a known standardized solution.

Innolitics

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