CARBON DIOXIDE LIQUID STABLE REAGENT— 510(k) K070251

Name: FDA 510(k) clearance K070251
Creator: U.S. Food and Drug Administration
Published: 2007-04-30

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K070251 for CARBON DIOXIDE LIQUID STABLE REAGENT, Substantially Equivalent on 2007-04-30. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 2007-01-26
Decision date: 2007-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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