SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P— 510(k) K992800

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K992800 for SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P, Substantially Equivalent on 1999-09-28. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code CDQ
Advisory panel: Clinical Chemistry
Date received: 1999-08-19
Decision date: 1999-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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