ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14— 510(k) K904660

Name: FDA 510(k) clearance K904660
Creator: U.S. Food and Drug Administration
Published: 1990-11-20

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K904660 for ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14, Substantially Equivalent on 1990-11-20. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code JFM
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1990-10-15
Decision date: 1990-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

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