LIPASE-PS ASSAY PROCEDURE NO. 805— 510(k) K941085

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K941085 for LIPASE-PS ASSAY PROCEDURE NO. 805, Substantially Equivalent on 1994-05-17. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code CHI
Advisory panel: Clinical Chemistry
Date received: 1994-03-08
Decision date: 1994-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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