ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245— 510(k) K954840

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K954840 for ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245, Substantially Equivalent on 1996-02-28. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code CJE
Advisory panel: Clinical Chemistry
Date received: 1995-10-20
Decision date: 1996-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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