ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H— 510(k) K000067

Name: FDA 510(k) clearance K000067
Creator: U.S. Food and Drug Administration
Published: 2000-01-20

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K000067 for ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H, Substantially Equivalent on 2000-01-20. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2000-01-10
Decision date: 2000-01-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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