CRP DIAGNOSTIC ASSAY— 510(k) K050836

Substantially Equivalent

Sentinel Ch. Srl

FDA 510(k) clearance K050836 for CRP DIAGNOSTIC ASSAY, Substantially Equivalent on 2005-08-08. Applicant: Sentinel Ch. Srl. Device class: 2.

Clearance details

Applicant: Sentinel Ch. Srl
Product code: Code DCK
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2005-04-01
Decision date: 2005-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rome, IT

Download summary PDF View on FDA.gov ↗

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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.