alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL— 510(k) K182474

Substantially Equivalent

Biosystems S.A.

FDA 510(k) clearance K182474 for alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL, Substantially Equivalent on 2019-05-02. Applicant: Biosystems S.A..

Clearance details

Applicant: Biosystems S.A.
Product code: Code JFJ
Advisory panel: Clinical Chemistry
Date received: 2018-09-10
Decision date: 2019-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

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