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FDA 510(k)

BLOOD UREA NITROGEN REAGENT SYS

K-Number: K840213 · 1984-03-19

ApplicantSclavo, Inc.
Decision Date1984-03-19
Product CodeJGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD UREA NITROGEN REAGENT SYS is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K840213. 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 SYS?

BLOOD UREA NITROGEN REAGENT SYS is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Sclavo, Inc.. The 510(k) number is K840213.

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

BLOOD UREA NITROGEN REAGENT SYS received FDA 510(k) clearance on 1984-03-19, under 510(k) number K840213.

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

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

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

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

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Other records listing Sclavo, Inc. as applicant

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K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

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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.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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