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FDA 510(k)

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR

K-Number: K852317 · 1985-06-25

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1985-06-25
Product CodeKLQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR 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 1985-06-25 under 510(k) number K852317. The device is classified under product code KLQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR?

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K852317.

When did COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR receive FDA 510(k) clearance?

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR received FDA 510(k) clearance on 1985-06-25, under 510(k) number K852317.

Who is the listed applicant for COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR?

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 FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR?

The FDA product code for COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR is KLQ.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: KLQ)

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.

K052815QMS AMIKACIN REAGENTSSeradyn, Inc.K033884RANDOX AMIKACINRandox Laboratories, Ltd.K955570INNOFLUOR AMIKACIN ASSAY SYSTEMOxis Intl., Inc.K903100INNOFLUOR (TM) AMIKACIN REAGENT SETInnotron of Oregon, Inc.K894517FPR AMIKACIN KITColony Laboratories, Inc.K843211AMIKACIN ANALYTICAL TEST PACK ACAE.I. Dupont DE Nemours & Co., 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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