LIQUID ALKALINE PHOSHATASE REAGENT SET— 510(k) K973588

Name: FDA 510(k) clearance K973588
Creator: U.S. Food and Drug Administration
Published: 1997-10-22

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K973588 for LIQUID ALKALINE PHOSHATASE REAGENT SET, Substantially Equivalent on 1997-10-22. Applicant: Pointe Scientific, Inc.,. Device class: 2.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1997-09-22
Decision date: 1997-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, US

Download summary PDF View on FDA.gov ↗

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