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FDA 510(k)

ENI BLOOD UREA NITROGEN REAGENT

K-Number: K844065 · 1984-11-27

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1984-11-27
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENI BLOOD UREA NITROGEN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1984-11-27 under 510(k) number K844065. 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 ENI BLOOD UREA NITROGEN REAGENT?

ENI BLOOD UREA NITROGEN REAGENT is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K844065.

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

ENI BLOOD UREA NITROGEN REAGENT received FDA 510(k) clearance on 1984-11-27, under 510(k) number K844065.

Who is the listed applicant for ENI BLOOD UREA NITROGEN REAGENT?

The FDA 510(k) record lists Electro-Nucleonics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for ENI BLOOD UREA NITROGEN REAGENT is CDQ.

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Other records listing Electro-Nucleonics Laboratories, Inc. as applicant

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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.

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