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FDA 510(k)

COBAS REAGENTS PHENOBARBITAL & PHENOBAR

K-Number: K843825 · 1985-02-01

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-02-01
Product CodeLGQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS REAGENTS PHENOBARBITAL & PHENOBAR 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 1985-02-01 under 510(k) number K843825. The device is classified under product code LGQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS REAGENTS PHENOBARBITAL & PHENOBAR?

COBAS REAGENTS PHENOBARBITAL & PHENOBAR is a medical device that received FDA 510(k) clearance on 1985-02-01. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K843825.

When did COBAS REAGENTS PHENOBARBITAL & PHENOBAR receive FDA 510(k) clearance?

COBAS REAGENTS PHENOBARBITAL & PHENOBAR received FDA 510(k) clearance on 1985-02-01, under 510(k) number K843825.

Who is the listed applicant for COBAS REAGENTS PHENOBARBITAL & PHENOBAR?

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 REAGENTS PHENOBARBITAL & PHENOBAR?

The FDA product code for COBAS REAGENTS PHENOBARBITAL & PHENOBAR is LGQ.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: LGQ)

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.

K972331INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K972330INNOFLUOR PHENOBARBITAL ASSAY SYSTEMOxis Intl., Inc.K940596AXSYM PHENOBARBITALAbbott LaboratoriesK936130COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORSRoche Diagnostic Systems, Inc.K900704MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRAInnotron of Oregon, Inc.K894525FPR PHENOBARBITAL KITColony Laboratories, 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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