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FDA 510(k)

FOCUS UREA NITROGEN

K-Number: K844755 · 1985-01-08

ApplicantAbbott Laboratories
Decision Date1985-01-08
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FOCUS 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 1985-01-08 under 510(k) number K844755. 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 FOCUS UREA NITROGEN?

FOCUS UREA NITROGEN is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Abbott Laboratories. The 510(k) number is K844755.

When did FOCUS UREA NITROGEN receive FDA 510(k) clearance?

FOCUS UREA NITROGEN received FDA 510(k) clearance on 1985-01-08, under 510(k) number K844755.

Who is the listed applicant for FOCUS 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 FOCUS UREA NITROGEN?

The FDA product code for FOCUS UREA NITROGEN is CDQ.

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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 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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