BUN(ENDPOINT) REAGENT— 510(k) K852131

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K852131 for BUN(ENDPOINT) REAGENT, Substantially Equivalent on 1985-06-10. Applicant: Sigma Diagnostics, Inc..

Clearance details

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