BUN (LIQUID) REAGENT SET— 510(k) K972671

Name: FDA 510(k) clearance K972671
Creator: U.S. Food and Drug Administration
Published: 1997-07-20

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K972671 for BUN (LIQUID) REAGENT SET, Substantially Equivalent on 1997-07-20. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 1997-07-16
Decision date: 1997-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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