Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UREA NITROGEN (BUN)

K-Number: K880078 · 1988-02-11

ApplicantTech-Neal Scientific, Inc.
Decision Date1988-02-11
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN (BUN) is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Neal Scientific, Inc.. It received FDA 510(k) clearance on 1988-02-11 under 510(k) number K880078. 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 NITROGEN (BUN)?

UREA NITROGEN (BUN) is a medical device that received FDA 510(k) clearance on 1988-02-11. The listed applicant is Tech-Neal Scientific, Inc.. The 510(k) number is K880078.

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

UREA NITROGEN (BUN) received FDA 510(k) clearance on 1988-02-11, under 510(k) number K880078.

Who is the listed applicant for UREA NITROGEN (BUN)?

The FDA 510(k) record lists Tech-Neal Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UREA NITROGEN (BUN)?

The FDA product code for UREA NITROGEN (BUN) is CDQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tech-Neal Scientific, 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.

K882256MAGNESIUM REAGENT SETK882459DIAZO, COLORIMETRIC BILIRUBINK881239GAMMA GLUTAMYL TRANSFERASE REAGENT SETK881241TOTAL BILIRUBIN REAGENTK881240CHLORIDE REAGENT SETK880237CHOLESTEROL

View all 20 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.

↑