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FDA 510(k)

SENTINEL CERULOPLASMIN

K-Number: K051456 · 2005-10-21

ApplicantSentinel Ch. Srl
Decision Date2005-10-21
Product CodeJFR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SENTINEL CERULOPLASMIN is the device name listed in this FDA 510(k) record. The listed applicant is Sentinel Ch. Srl. It received FDA 510(k) clearance on 2005-10-21 under 510(k) number K051456. The device is classified under product code JFR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENTINEL CERULOPLASMIN?

SENTINEL CERULOPLASMIN is a medical device that received FDA 510(k) clearance on 2005-10-21. The listed applicant is Sentinel Ch. Srl. The 510(k) number is K051456.

When did SENTINEL CERULOPLASMIN receive FDA 510(k) clearance?

SENTINEL CERULOPLASMIN received FDA 510(k) clearance on 2005-10-21, under 510(k) number K051456.

Who is the listed applicant for SENTINEL CERULOPLASMIN?

The FDA 510(k) record lists Sentinel Ch. Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENTINEL CERULOPLASMIN?

The FDA product code for SENTINEL CERULOPLASMIN is JFR.

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Other records listing Sentinel Ch. Srl as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K070971MODIFICATION TO SENTINEL CLIN CHEM CALK051447SENTINEL PANCREATIC AMYLASEK051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYK051111SENTINEL UIBC LIQUIDK051452SENTINEL CLIN CHEM CALK051115SENTINEL IRON LIQUID

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Related Devices (Code: JFR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K882622CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEMTechnicon Instruments Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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