OPUS D-DIMER— 510(k) K972316

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K972316 for OPUS D-DIMER, Substantially Equivalent on 1997-09-09. Applicant: Behring Diagnostics, Inc..

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GHH
Advisory panel: Hematology
Date received: 1997-06-20
Decision date: 1997-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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