CHEK-STIX CONTROL STRIPS FOR URINALYSIS— 510(k) K931467

Name: FDA 510(k) clearance K931467
Creator: U.S. Food and Drug Administration
Published: 1993-05-11

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K931467 for CHEK-STIX CONTROL STRIPS FOR URINALYSIS, Substantially Equivalent on 1993-05-11. Applicant: Heraeus Kulzer, Inc.. Device class: 1.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1993-03-24
Decision date: 1993-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mishawaka, IN, US

Download summary PDF View on FDA.gov ↗

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