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FDA 510(k)

EASYRA UREA NITROGEN AND CREATININE REAGENTS

K-Number: K110675 · 2011-04-21

ApplicantMedica Corp.
Decision Date2011-04-21
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASYRA UREA NITROGEN AND CREATININE REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 2011-04-21 under 510(k) number K110675. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYRA UREA NITROGEN AND CREATININE REAGENTS?

EASYRA UREA NITROGEN AND CREATININE REAGENTS is a medical device that received FDA 510(k) clearance on 2011-04-21. The listed applicant is Medica Corp.. The 510(k) number is K110675.

When did EASYRA UREA NITROGEN AND CREATININE REAGENTS receive FDA 510(k) clearance?

EASYRA UREA NITROGEN AND CREATININE REAGENTS received FDA 510(k) clearance on 2011-04-21, under 510(k) number K110675.

Who is the listed applicant for EASYRA UREA NITROGEN AND CREATININE REAGENTS?

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 UREA NITROGEN AND CREATININE REAGENTS?

The FDA product code for EASYRA UREA NITROGEN AND CREATININE REAGENTS is CDQ.

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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/PHK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

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Related Devices (Code: CDQ)

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.

K203771Urea Nitrogen2Abbott Ireland Diagnostics DivisionK073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OYK070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba AbxK060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMTeco DiagnosticsK041051RAICHEM BUN RATE REAGENT (LIQUID)Hemagen Diagnostics, Inc.K024182PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTSPrecision Systems, 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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