RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)— 510(k) K871509

Name: FDA 510(k) clearance K871509
Creator: U.S. Food and Drug Administration
Published: 1987-05-08

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K871509 for RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL), Substantially Equivalent on 1987-05-08. Applicant: Trace Scientific , Ltd.. Device class: 1.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1987-04-16
Decision date: 1987-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

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