ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119— 510(k) K000528

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K000528 for ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119, Substantially Equivalent on 2000-04-07. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code GIR
Advisory panel: Hematology
Date received: 2000-02-17
Decision date: 2000-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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