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FDA 510(k)

MICROALBUMIN MULTI-CALIBRATOR SET

K-Number: K042243 · 2004-10-04

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2004-10-04
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROALBUMIN MULTI-CALIBRATOR SET 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 2004-10-04 under 510(k) number K042243. 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 MICROALBUMIN MULTI-CALIBRATOR SET?

MICROALBUMIN MULTI-CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 2004-10-04. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K042243.

When did MICROALBUMIN MULTI-CALIBRATOR SET receive FDA 510(k) clearance?

MICROALBUMIN MULTI-CALIBRATOR SET received FDA 510(k) clearance on 2004-10-04, under 510(k) number K042243.

Who is the listed applicant for MICROALBUMIN MULTI-CALIBRATOR SET?

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 MICROALBUMIN MULTI-CALIBRATOR SET?

The FDA product code for MICROALBUMIN MULTI-CALIBRATOR SET is JIX.

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Other records listing Diagnostic Chemicals , Ltd. 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.

K070383ENZYMATIC CREATININE ASSAY (265 SERIES)K063208MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7K060139CRP-ADVANCE ASSAY, MODELS 250-20, 250-25K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250K051757CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91K051191DCL MICROALBUMIN ASSAY, MODEL 252-20

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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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