URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)— 510(k) K954977

Name: FDA 510(k) clearance K954977
Creator: U.S. Food and Drug Administration
Published: 1996-03-11

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K954977 for URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION), Substantially Equivalent on 1996-03-11. Applicant: Teco Diagnostics. Device class: 1.

Clearance details

Applicant: Teco Diagnostics
Product code: Code JRE
Device class: Class 1
Regulation: 21 CFR 862.2800
Advisory panel: Clinical Chemistry
Date received: 1995-10-16
Decision date: 1996-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JRE

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K941903 — MODEL 2740 CLINICAL REFRACTOMETER1995-01-17
K941906 — MODEL 2730 CLINICAL REFRACTOMETER1995-01-17
K941902 — MODEL 3471 CLINICAL REFRACTOMETER1994-12-13
K941904 — MODEL A300CL CLINICAL REFRACTOMETER1994-12-13

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