5STRATEC SL 300 LIA-MAT

K950029 · Nichols Institute Diagnostics · JJQ · Aug 2, 1995 · Clinical Chemistry

Device Facts

Record IDK950029
Device Name5STRATEC SL 300 LIA-MAT
ApplicantNichols Institute Diagnostics
Product CodeJJQ · Clinical Chemistry
Decision DateAug 2, 1995
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 862.2300
Device ClassClass 1

Regulatory Classification

Identification

A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.

Innolitics

Panel 1

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