FLEXSURE OBT— 510(k) K961062

Substantially Equivalent

Smithkline Diagnostics, Inc.

FDA 510(k) clearance K961062 for FLEXSURE OBT, Substantially Equivalent on 1996-11-06. Applicant: Smithkline Diagnostics, Inc..

Clearance details

Applicant: Smithkline Diagnostics, Inc.
Product code: Code KHE
Advisory panel: Hematology
Date received: 1996-03-18
Decision date: 1996-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sharon Hill, PA, US

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