X-AMYLASE ASSAY KIT— 510(k) K852636

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K852636 for X-AMYLASE ASSAY KIT, Substantially Equivalent on 1985-07-12. Applicant: Diagnostic Chemicals, Ltd. (Usa).

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CIJ
Advisory panel: Clinical Chemistry
Date received: 1985-06-20
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

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