HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD— 510(k) K870363

Name: FDA 510(k) clearance K870363
Creator: U.S. Food and Drug Administration
Published: 1987-03-16

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K870363 for HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD, Substantially Equivalent on 1987-03-16. Applicant: Trace Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1987-01-28
Decision date: 1987-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

Download summary PDF View on FDA.gov ↗

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