SENTINEL CERULOPLASMIN— 510(k) K051456

Substantially Equivalent

Sentinel Ch. Srl

FDA 510(k) clearance K051456 for SENTINEL CERULOPLASMIN, Substantially Equivalent on 2005-10-21. Applicant: Sentinel Ch. Srl. Device class: 2.

Clearance details

Applicant: Sentinel Ch. Srl
Product code: Code JFR
Device class: Class 2
Regulation: 21 CFR 866.5210
Advisory panel: Immunology
Date received: 2005-06-02
Decision date: 2005-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milano, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFR

K882622 — CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM1988-07-08

More clearances from Sentinel Ch. Srl

K070971 — MODIFICATION TO SENTINEL CLIN CHEM CAL2007-05-23
K051447 — SENTINEL PANCREATIC AMYLASE2006-01-26
K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY2005-11-25
K051111 — SENTINEL UIBC LIQUID2005-11-17
K051452 — SENTINEL CLIN CHEM CAL2005-10-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.