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FDA 510(k)

BLOOD UREA NITROGEN REAGENT

K-Number: K792362 · 1979-12-06

ApplicantConnecticut Diagnostics, Ltd.
Decision Date1979-12-06
Product CodeJGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD UREA NITROGEN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Connecticut Diagnostics, Ltd.. It received FDA 510(k) clearance on 1979-12-06 under 510(k) number K792362. 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 BLOOD UREA NITROGEN REAGENT?

BLOOD UREA NITROGEN REAGENT is a medical device that received FDA 510(k) clearance on 1979-12-06. The listed applicant is Connecticut Diagnostics, Ltd.. The 510(k) number is K792362.

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

BLOOD UREA NITROGEN REAGENT received FDA 510(k) clearance on 1979-12-06, under 510(k) number K792362.

Who is the listed applicant for BLOOD UREA NITROGEN REAGENT?

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

What is the FDA product code for BLOOD UREA NITROGEN REAGENT?

The FDA product code for BLOOD UREA NITROGEN REAGENT is JGZ.

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Other records listing Connecticut Diagnostics, Ltd. 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.

K905617VISI-STAPHK822500CDL LYSING REAGENTK822501CDL ISOTONIC DILUENTK822504CDL AUTO-LYSING REAGENTK811222INORGANIC PHOSPHORUS REAGENTSK801897GLUCOSE DIAGNOSTIC REAGENT

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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.K863901IQ UREA NITROGENBd Becton Dickinson Vacutainer Systems PreanalyticK842772PHARMACIA B2-MICRO RIAPharmacia, Inc.K840213BLOOD UREA NITROGEN REAGENT SYSSclavo, 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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