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FDA 510(k)

COBAS REAGENTS FOR GENTAMICIN & CALIBRAT

K-Number: K843827 · 1985-02-01

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

Device Summary

COBAS REAGENTS FOR GENTAMICIN & CALIBRAT 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 K843827. The device is classified under product code LCQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS REAGENTS FOR GENTAMICIN & CALIBRAT?

COBAS REAGENTS FOR GENTAMICIN & CALIBRAT 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 K843827.

When did COBAS REAGENTS FOR GENTAMICIN & CALIBRAT receive FDA 510(k) clearance?

COBAS REAGENTS FOR GENTAMICIN & CALIBRAT received FDA 510(k) clearance on 1985-02-01, under 510(k) number K843827.

Who is the listed applicant for COBAS REAGENTS FOR GENTAMICIN & CALIBRAT?

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 FOR GENTAMICIN & CALIBRAT?

The FDA product code for COBAS REAGENTS FOR GENTAMICIN & CALIBRAT is LCQ.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: LCQ)

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.

K972609VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAMBio-RadK955569INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.K945523COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORSRoche Diagnostic Systems, Inc.K943550GENTAMICIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.K905721OPUS GENTAMICINPb Diagnostic Systems, Inc.K904226'TDXFLX ANALYZERAbbott Laboratories

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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