INFINITY HBA KIT, MODELS 537-A, 537-B— 510(k) K012410

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K012410 for INFINITY HBA KIT, MODELS 537-A, 537-B, Substantially Equivalent on 2001-10-26. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2001-07-30
Decision date: 2001-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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