FACTOR VIII DEFICIENT PLASMA— 510(k) K935057

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K935057 for FACTOR VIII DEFICIENT PLASMA, Substantially Equivalent on 1994-03-15. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code GJT
Advisory panel: Hematology
Date received: 1993-10-21
Decision date: 1994-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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