STERICHEK BLOOD LEAK REAGENT STRIPS— 510(k) K042322

Name: FDA 510(k) clearance K042322
Creator: U.S. Food and Drug Administration
Published: 2004-12-07

Substantially Equivalent

Hach Company

FDA 510(k) clearance K042322 for STERICHEK BLOOD LEAK REAGENT STRIPS, Substantially Equivalent on 2004-12-07. Applicant: Hach Company. Device class: 2.

Clearance details

Applicant: Hach Company
Product code: Code FJD
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2004-08-26
Decision date: 2004-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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