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FDA 510(k)

DC-UIBC-CO2-CAL, MODEL SE-153

K-Number: K013178 · 2001-12-18

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2001-12-18
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DC-UIBC-CO2-CAL, MODEL SE-153 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2001-12-18 under 510(k) number K013178. 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 DC-UIBC-CO2-CAL, MODEL SE-153?

DC-UIBC-CO2-CAL, MODEL SE-153 is a medical device that received FDA 510(k) clearance on 2001-12-18. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K013178.

When did DC-UIBC-CO2-CAL, MODEL SE-153 receive FDA 510(k) clearance?

DC-UIBC-CO2-CAL, MODEL SE-153 received FDA 510(k) clearance on 2001-12-18, under 510(k) number K013178.

Who is the listed applicant for DC-UIBC-CO2-CAL, MODEL SE-153?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DC-UIBC-CO2-CAL, MODEL SE-153?

The FDA product code for DC-UIBC-CO2-CAL, MODEL SE-153 is JIX.

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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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