THROMBOMAX-HS WITH CALCIUM, MODEL T6540— 510(k) K010158

Name: FDA 510(k) clearance K010158
Creator: U.S. Food and Drug Administration
Published: 2001-03-22

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K010158 for THROMBOMAX-HS WITH CALCIUM, MODEL T6540, Substantially Equivalent on 2001-03-22. Applicant: Sigma Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code GGO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2001-01-17
Decision date: 2001-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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