BICARBONATE (CO2) REAGENT-2 VIAL— 510(k) K881938

Name: FDA 510(k) clearance K881938
Creator: U.S. Food and Drug Administration
Published: 1988-06-15

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K881938 for BICARBONATE (CO2) REAGENT-2 VIAL, Substantially Equivalent on 1988-06-15. Applicant: Trace Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code KHS
Device class: Class 2
Regulation: 21 CFR 862.1160
Advisory panel: Clinical Chemistry
Date received: 1988-05-09
Decision date: 1988-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

Download summary PDF View on FDA.gov ↗

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