DeviceClearance

SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217— 510(k) K003329

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K003329 for SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217, Substantially Equivalent on 2001-03-01. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant
Sigma Diagnostics, Inc.
Product code
Code GGC
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Louis, MO, US
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