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FDA 510(k)

CARESIDE BUN

K-Number: K980057 · 1998-02-05

ApplicantExigent Diagnostics, Inc.
Decision Date1998-02-05
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESIDE BUN is the device name listed in this FDA 510(k) record. The listed applicant is Exigent Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-02-05 under 510(k) number K980057. 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 CARESIDE BUN?

CARESIDE BUN is a medical device that received FDA 510(k) clearance on 1998-02-05. The listed applicant is Exigent Diagnostics, Inc.. The 510(k) number is K980057.

When did CARESIDE BUN receive FDA 510(k) clearance?

CARESIDE BUN received FDA 510(k) clearance on 1998-02-05, under 510(k) number K980057.

Who is the listed applicant for CARESIDE BUN?

The FDA 510(k) record lists Exigent Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARESIDE BUN?

The FDA product code for CARESIDE BUN is CDQ.

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Other records listing Exigent Diagnostics, Inc. 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.

K982118CARESIDE ANALYZERK981899CARESIDE HDL-CHOLESTEROLK981183CARESIDE GLUCOSEK980043CARESIDE CREATININEK980056CARESIDE ANALYZERK980041CARESIDE ALBUMIN

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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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