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FDA 510(k)

UREA

K-Number: K981123 · 1998-04-24

ApplicantTrace Scientific , Ltd.
Decision Date1998-04-24
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1998-04-24 under 510(k) number K981123. 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 UREA?

UREA is a medical device that received FDA 510(k) clearance on 1998-04-24. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K981123.

When did UREA receive FDA 510(k) clearance?

UREA received FDA 510(k) clearance on 1998-04-24, under 510(k) number K981123.

Who is the listed applicant for UREA?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UREA?

The FDA product code for UREA is CDQ.

Other records listing Trace Scientific , 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGEK932713TRACE TRANSFERRIN REAGENT

View all 55 devices →

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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