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FDA 510(k)

MODIFICATION TO SENTINEL CLIN CHEM CAL

K-Number: K070971 · 2007-05-23

ApplicantSentinel Ch. Srl
Decision Date2007-05-23
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SENTINEL CLIN CHEM CAL 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 2007-05-23 under 510(k) number K070971. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SENTINEL CLIN CHEM CAL?

MODIFICATION TO SENTINEL CLIN CHEM CAL is a medical device that received FDA 510(k) clearance on 2007-05-23. The listed applicant is Sentinel Ch. Srl. The 510(k) number is K070971.

When did MODIFICATION TO SENTINEL CLIN CHEM CAL receive FDA 510(k) clearance?

MODIFICATION TO SENTINEL CLIN CHEM CAL received FDA 510(k) clearance on 2007-05-23, under 510(k) number K070971.

Who is the listed applicant for MODIFICATION TO SENTINEL CLIN CHEM CAL?

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 MODIFICATION TO SENTINEL CLIN CHEM CAL?

The FDA product code for MODIFICATION TO SENTINEL CLIN CHEM CAL is JIX.

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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.

K051447SENTINEL PANCREATIC AMYLASEK051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYK051111SENTINEL UIBC LIQUIDK051452SENTINEL CLIN CHEM CALK051456SENTINEL CERULOPLASMINK051115SENTINEL IRON LIQUID

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

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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