IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET— 510(k) K942648

Name: FDA 510(k) clearance K942648
Creator: U.S. Food and Drug Administration
Published: 1995-03-24

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K942648 for IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET, Substantially Equivalent on 1995-03-24. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1994-06-03
Decision date: 1995-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

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