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FDA 510(k)

COBAS READY BUN REAGENT

K-Number: K896236 · 1990-02-27

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-02-27
Product CodeJGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS READY BUN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-02-27 under 510(k) number K896236. 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 COBAS READY BUN REAGENT?

COBAS READY BUN REAGENT is a medical device that received FDA 510(k) clearance on 1990-02-27. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K896236.

When did COBAS READY BUN REAGENT receive FDA 510(k) clearance?

COBAS READY BUN REAGENT received FDA 510(k) clearance on 1990-02-27, under 510(k) number K896236.

Who is the listed applicant for COBAS READY BUN REAGENT?

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

What is the FDA product code for COBAS READY BUN REAGENT?

The FDA product code for COBAS READY BUN REAGENT is JGZ.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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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.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.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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