DeviceClearance

SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P— 510(k) K001403

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K001403 for SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P, Substantially Equivalent on 2000-08-10. Applicant: Sigma Diagnostics, Inc..

Clearance details

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