GRAM STAIN KIT— 510(k) K853896

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K853896 for GRAM STAIN KIT, Substantially Equivalent on 1985-10-22. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code JTS
Advisory panel: Hematology
Date received: 1985-09-20
Decision date: 1985-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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