URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD— 510(k) K946116

Name: FDA 510(k) clearance K946116
Creator: U.S. Food and Drug Administration
Published: 1995-03-21

Substantially Equivalent

Chemtech Labs, Inc.

FDA 510(k) clearance K946116 for URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BLOOD, Substantially Equivalent on 1995-03-21. Applicant: Chemtech Labs, Inc.. Device class: 2.

Clearance details

Applicant: Chemtech Labs, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1994-12-15
Decision date: 1995-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gurnee, IL, US

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