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FDA 510(k)

UREA NITROGEN, KINETIC

K-Number: K810087 · 1981-02-26

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1981-02-26
Product CodeJGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN, KINETIC is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1981-02-26 under 510(k) number K810087. 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 UREA NITROGEN, KINETIC?

UREA NITROGEN, KINETIC is a medical device that received FDA 510(k) clearance on 1981-02-26. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K810087.

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

UREA NITROGEN, KINETIC received FDA 510(k) clearance on 1981-02-26, under 510(k) number K810087.

Who is the listed applicant for UREA NITROGEN, KINETIC?

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

What is the FDA product code for UREA NITROGEN, KINETIC?

The FDA product code for UREA NITROGEN, KINETIC is JGZ.

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Other records listing Bio-Analytics Laboratories, Inc. 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.

K861638KINETIC ALKALINE PHOSPHATASE REAGENT KITK860245ENZYMATIC ALPHA-AMYLASE REAGENT KITK860213ALBUMIN REAGENT KITK851513ULTRA-VIOLET BUN REAGENT KITK851514ULTRA-VIOLET GLUCOSE REAGENTK850639ENZYMATIC ALPHA-AMYLASE REAGENT KIT

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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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