EON CALCIUM REGENT— 510(k) K120626

Substantially Equivalent

Vital Diagnostics (Manufacturing) Ptyltd

FDA 510(k) clearance K120626 for EON CALCIUM REGENT, Substantially Equivalent on 2012-08-22. Applicant: Vital Diagnostics (Manufacturing) Ptyltd.

Clearance details

Applicant: Vital Diagnostics (Manufacturing) Ptyltd
Product code: Code CJY
Advisory panel: Clinical Chemistry
Date received: 2012-03-01
Decision date: 2012-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noble Park, AU

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