DIA SCREEN 10 WAY REAGENT STRIPS— 510(k) K961375

Name: FDA 510(k) clearance K961375
Creator: U.S. Food and Drug Administration
Published: 1996-06-18

Substantially Equivalent

Genesis Labs, Inc.

FDA 510(k) clearance K961375 for DIA SCREEN 10 WAY REAGENT STRIPS, Substantially Equivalent on 1996-06-18. Applicant: Genesis Labs, Inc.. Device class: 2.

Clearance details

Applicant: Genesis Labs, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1996-04-09
Decision date: 1996-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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