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FDA 510(k)

COBAS INTEGRA AMIKACIN MAB

K-Number: K991597 · 1999-07-22

ApplicantRoche Diagnostics Corp.
Decision Date1999-07-22
Product CodeLGJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA AMIKACIN MAB is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 1999-07-22 under 510(k) number K991597. The device is classified under product code LGJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS INTEGRA AMIKACIN MAB?

COBAS INTEGRA AMIKACIN MAB is a medical device that received FDA 510(k) clearance on 1999-07-22. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K991597.

When did COBAS INTEGRA AMIKACIN MAB receive FDA 510(k) clearance?

COBAS INTEGRA AMIKACIN MAB received FDA 510(k) clearance on 1999-07-22, under 510(k) number K991597.

Who is the listed applicant for COBAS INTEGRA AMIKACIN MAB?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS INTEGRA AMIKACIN MAB?

The FDA product code for COBAS INTEGRA AMIKACIN MAB is LGJ.

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Other records listing Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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Related Devices (Code: LGJ)

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.

K941712COBAS-FP REAGENTS AND CALIBRATORSRoche Diagnostic Systems, Inc.K862248AMIKACIN KIT (FPIA)Windsor 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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