BAYER RAPIDPOINT 405 SYSTEM— 510(k) K020616

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K020616 for BAYER RAPIDPOINT 405 SYSTEM, Substantially Equivalent on 2002-07-17. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code GKR
Advisory panel: Hematology
Date received: 2002-02-25
Decision date: 2002-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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