ALP (ALKALINE PHOSPHATASE) REAGENT— 510(k) K860715

Name: FDA 510(k) clearance K860715
Creator: U.S. Food and Drug Administration
Published: 1986-04-24

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K860715 for ALP (ALKALINE PHOSPHATASE) REAGENT, Substantially Equivalent on 1986-04-24. Applicant: Trace Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1986-02-26
Decision date: 1986-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

Download summary PDF View on FDA.gov ↗

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