DIMENSION TPSA CALIBRATOR, MODEL #RC459— 510(k) K020980

Substantially Equivalent

Dade Behring, Inc.

FDA 510(k) clearance K020980 for DIMENSION TPSA CALIBRATOR, MODEL #RC459, Substantially Equivalent on 2002-06-21. Applicant: Dade Behring, Inc..

Clearance details

Applicant: Dade Behring, Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2002-03-26
Decision date: 2002-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newark, DE, US

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