LIPASE REAGENT SET (COLIPASE METHOD)— 510(k) K970124

Name: FDA 510(k) clearance K970124
Creator: U.S. Food and Drug Administration
Published: 1997-03-06

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K970124 for LIPASE REAGENT SET (COLIPASE METHOD), Substantially Equivalent on 1997-03-06. Applicant: Teco Diagnostics. Device class: 1.

Clearance details

Applicant: Teco Diagnostics
Product code: Code CET
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1997-01-14
Decision date: 1997-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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K885078 — LIPASE SR LIQUID STABLE REAGENT SET1989-03-13

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