TRACE GAMMA GT-SS REAGENT— 510(k) K914731

Name: FDA 510(k) clearance K914731
Creator: U.S. Food and Drug Administration
Published: 1991-11-19

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K914731 for TRACE GAMMA GT-SS REAGENT, Substantially Equivalent on 1991-11-19. Applicant: Trace Scientific , Ltd.. Device class: 1.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1991-10-21
Decision date: 1991-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

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