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)

BUN

K-Number: K781782 · 1979-01-10

ApplicantGilford Diagnostics
Decision Date1979-01-10
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1979-01-10 under 510(k) number K781782. 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 BUN?

BUN is a medical device that received FDA 510(k) clearance on 1979-01-10. The listed applicant is Gilford Diagnostics. The 510(k) number is K781782.

When did BUN receive FDA 510(k) clearance?

BUN received FDA 510(k) clearance on 1979-01-10, under 510(k) number K781782.

Who is the listed applicant for BUN?

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

What is the FDA product code for BUN?

The FDA product code for BUN is CDQ.

Other records listing Gilford Diagnostics 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.

K832094BILIRUBIN CALIBRATORS & CONTROLK831844DIRECT BILIRUBIN REAGENTK831843GILCHEM TOTAL BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORS

View all 50 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.

↑