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FDA 510(k)

A-GENT UREA NITROGEN

K-Number: K810794 · 1981-04-01

ApplicantAbbott Laboratories
Decision Date1981-04-01
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A-GENT UREA NITROGEN is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1981-04-01 under 510(k) number K810794. 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 A-GENT UREA NITROGEN?

A-GENT UREA NITROGEN is a medical device that received FDA 510(k) clearance on 1981-04-01. The listed applicant is Abbott Laboratories. The 510(k) number is K810794.

When did A-GENT UREA NITROGEN receive FDA 510(k) clearance?

A-GENT UREA NITROGEN received FDA 510(k) clearance on 1981-04-01, under 510(k) number K810794.

Who is the listed applicant for A-GENT UREA NITROGEN?

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

What is the FDA product code for A-GENT UREA NITROGEN?

The FDA product code for A-GENT UREA NITROGEN is CDQ.

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Related Devices (Code: CDQ)

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K203771Urea Nitrogen2Abbott Ireland Diagnostics DivisionK110675EASYRA UREA NITROGEN AND CREATININE REAGENTSMedica Corp.K073295UREA/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.

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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