ACE CALIBRATOR— 510(k) K141728

Substantially Equivalent

SENTINEL CH. SpA

FDA 510(k) clearance K141728 for ACE CALIBRATOR, Substantially Equivalent on 2014-07-28. Applicant: SENTINEL CH. SpA. Device class: 2.

Clearance details

Applicant: SENTINEL CH. SpA
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2014-06-26
Decision date: 2014-07-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Milan, IT

Download summary PDF View on FDA.gov ↗

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