LD1 ISOENZYME REAGENT KIT— 510(k) K890996

Name: FDA 510(k) clearance K890996
Creator: U.S. Food and Drug Administration
Published: 1989-05-05

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K890996 for LD1 ISOENZYME REAGENT KIT, Substantially Equivalent on 1989-05-05. Applicant: Trace Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code JGF
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1989-02-27
Decision date: 1989-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

Download summary PDF View on FDA.gov ↗

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K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)1986-04-11

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