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FDA 510(k)

DCL MICROALBUMIN ASSAY, MODEL 252-20

K-Number: K051191 · 2005-07-05

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2005-07-05
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DCL MICROALBUMIN ASSAY, MODEL 252-20 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 2005-07-05 under 510(k) number K051191. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DCL MICROALBUMIN ASSAY, MODEL 252-20?

DCL MICROALBUMIN ASSAY, MODEL 252-20 is a medical device that received FDA 510(k) clearance on 2005-07-05. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K051191.

When did DCL MICROALBUMIN ASSAY, MODEL 252-20 receive FDA 510(k) clearance?

DCL MICROALBUMIN ASSAY, MODEL 252-20 received FDA 510(k) clearance on 2005-07-05, under 510(k) number K051191.

Who is the listed applicant for DCL MICROALBUMIN ASSAY, MODEL 252-20?

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 DCL MICROALBUMIN ASSAY, MODEL 252-20?

The FDA product code for DCL MICROALBUMIN ASSAY, MODEL 252-20 is DCF.

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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, 145-20-91K042330ACETAMINOPHEN-SL ASSAY

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Related Devices (Code: DCF)

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.

K153560Optilite Low Level Albumin KitThe Binding Site Group , Ltd.K121045HUMAN ALBUMIN CSF KITThe Binding Site Group , Ltd.K113072TINA-QUANT ALBUMIN GEN.2Roche Diagnostics OperationsK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORMedica Corp.K101203TINA-QUANT ALBUMIN GEN 2Roche DiagnosticsK100853COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics 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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