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FDA 510(k)

SENTINEL IRON LIQUID

K-Number: K051115 · 2005-08-25

ApplicantSentinel Ch. Srl
Decision Date2005-08-25
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SENTINEL IRON LIQUID 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 2005-08-25 under 510(k) number K051115. The device is classified under product code JIY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENTINEL IRON LIQUID?

SENTINEL IRON LIQUID is a medical device that received FDA 510(k) clearance on 2005-08-25. The listed applicant is Sentinel Ch. Srl. The 510(k) number is K051115.

When did SENTINEL IRON LIQUID receive FDA 510(k) clearance?

SENTINEL IRON LIQUID received FDA 510(k) clearance on 2005-08-25, under 510(k) number K051115.

Who is the listed applicant for SENTINEL IRON LIQUID?

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 IRON LIQUID?

The FDA product code for SENTINEL IRON LIQUID is JIY.

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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 CALK051456SENTINEL CERULOPLASMIN

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Related Devices (Code: JIY)

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.

K061793DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.K033983VITALAB IRON REAGENTClinical Data, Inc.K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical DataK020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , Ltd.K013097WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003Wiener Laboratories Saic

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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