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FDA 510(k)

IQ UREA NITROGEN

K-Number: K863901 · 1986-11-24

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1986-11-24
Product CodeJGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IQ UREA NITROGEN is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K863901. The device is classified under product code JGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IQ UREA NITROGEN?

IQ UREA NITROGEN is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K863901.

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

IQ UREA NITROGEN received FDA 510(k) clearance on 1986-11-24, under 510(k) number K863901.

Who is the listed applicant for IQ UREA NITROGEN?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IQ UREA NITROGEN?

The FDA product code for IQ UREA NITROGEN is JGZ.

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Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

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Related Devices (Code: JGZ)

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.

K904049ROCHE COBAS READY RENAL PROFILE REAGENT STRIPRoche Diagnostic Systems, Inc.K896236COBAS READY BUN REAGENTRoche Diagnostic Systems, Inc.K883327CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TESTHeraeus Kulzer, Inc.K842772PHARMACIA B2-MICRO RIAPharmacia, Inc.K840213BLOOD UREA NITROGEN REAGENT SYSSclavo, Inc.K820418K.D. COLORIMETRIC BLOOD UREA N2 TESTKing 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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