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FDA 510(k)

BLOOD UREA NITROGEN (BUN) TESTCARD

K-Number: K860543 · 1986-04-21

ApplicantIlex Corp.
Decision Date1986-04-21
Product CodeCDS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD UREA NITROGEN (BUN) TESTCARD is the device name listed in this FDA 510(k) record. The listed applicant is Ilex Corp.. It received FDA 510(k) clearance on 1986-04-21 under 510(k) number K860543. The device is classified under product code CDS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD UREA NITROGEN (BUN) TESTCARD?

BLOOD UREA NITROGEN (BUN) TESTCARD is a medical device that received FDA 510(k) clearance on 1986-04-21. The listed applicant is Ilex Corp.. The 510(k) number is K860543.

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

BLOOD UREA NITROGEN (BUN) TESTCARD received FDA 510(k) clearance on 1986-04-21, under 510(k) number K860543.

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

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

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

The FDA product code for BLOOD UREA NITROGEN (BUN) TESTCARD is CDS.

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 Ilex Corp. 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.

K860639IONIZED CALCIUM AND BLOOD PH TESTCARDSK853068ILEX PROMPT CLINICAL CHEMISTRY ANALYER

Related Devices (Code: CDS)

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.

K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc.K040973BUN REAGENTGenchem, Inc.K033056BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENTDiamond Diagnostics, Inc.K925550HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806Hichem DiagnosticsK855091CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYSSen Tech Medical Corp.K812308LANCER BUN RATE REAGENT KITSherwood Medical Co.

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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