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FDA 510(k)

EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

K-Number: K101089 · 2011-07-13

ApplicantMedica Corp.
Decision Date2011-07-13
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 2011-07-13 under 510(k) number K101089. 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 EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR?

EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR is a medical device that received FDA 510(k) clearance on 2011-07-13. The listed applicant is Medica Corp.. The 510(k) number is K101089.

When did EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR receive FDA 510(k) clearance?

EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR received FDA 510(k) clearance on 2011-07-13, under 510(k) number K101089.

Who is the listed applicant for EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR?

The FDA 510(k) record lists Medica Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR?

The FDA product code for EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR is DCF.

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Other records listing Medica Corp. 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.

K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTK120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALK111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALK111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALK112788EASTLYTE NA/K/CA/PHK101090EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS

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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 OperationsK101203TINA-QUANT ALBUMIN GEN 2Roche DiagnosticsK100853COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics Corp.K091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORKamiya Biomedical Co.

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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