DIA SCREEN REAGENT STRIPS— 510(k) K952971

Substantially Equivalent

Genesis Labs, Inc.

FDA 510(k) clearance K952971 for DIA SCREEN REAGENT STRIPS, Substantially Equivalent on 1995-08-11. 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: 1995-06-27
Decision date: 1995-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Genesis Labs, Inc.

K961375 — DIA SCREEN 10 WAY REAGENT STRIPS1996-06-18
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