DADE HEPZYME— 510(k) K925452

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K925452 for DADE HEPZYME, Substantially Equivalent on 1993-01-11. Applicant: Baxter Diagnostics, Inc..

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code JBR
Advisory panel: Hematology
Date received: 1992-10-28
Decision date: 1993-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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