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FDA 510(k)

CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST

K-Number: K883327 · 1989-01-23

ApplicantHeraeus Kulzer, Inc.
Decision Date1989-01-23
Product CodeJGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1989-01-23 under 510(k) number K883327. 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 CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST?

CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST is a medical device that received FDA 510(k) clearance on 1989-01-23. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K883327.

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

CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST received FDA 510(k) clearance on 1989-01-23, under 510(k) number K883327.

Who is the listed applicant for CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST?

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

What is the FDA product code for CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST?

The FDA product code for CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST is JGZ.

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Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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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.K863901IQ UREA NITROGENBd Becton Dickinson Vacutainer Systems PreanalyticK842772PHARMACIA 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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