URINE REAGENT STRIPS-8 PARAMETERS— 510(k) K943436

Name: FDA 510(k) clearance K943436
Creator: U.S. Food and Drug Administration
Published: 1995-04-24

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K943436 for URINE REAGENT STRIPS-8 PARAMETERS, Substantially Equivalent on 1995-04-24. Applicant: Teco Diagnostics. Device class: 1.

Clearance details

Applicant: Teco Diagnostics
Product code: Code JJB
Device class: Class 1
Regulation: 21 CFR 862.1115
Advisory panel: Clinical Chemistry
Date received: 1994-07-18
Decision date: 1995-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

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