BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04— 510(k) K861095

Name: FDA 510(k) clearance K861095
Creator: U.S. Food and Drug Administration
Published: 1986-04-21

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K861095 for BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04, Substantially Equivalent on 1986-04-21. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1986-03-24
Decision date: 1986-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

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