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FDA 510(k)

FPR AMIKACIN KIT

K-Number: K894517 · 1989-09-28

ApplicantColony Laboratories, Inc.
Decision Date1989-09-28
Product CodeKLQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FPR AMIKACIN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Colony Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-28 under 510(k) number K894517. 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 FPR AMIKACIN KIT?

FPR AMIKACIN KIT is a medical device that received FDA 510(k) clearance on 1989-09-28. The listed applicant is Colony Laboratories, Inc.. The 510(k) number is K894517.

When did FPR AMIKACIN KIT receive FDA 510(k) clearance?

FPR AMIKACIN KIT received FDA 510(k) clearance on 1989-09-28, under 510(k) number K894517.

Who is the listed applicant for FPR AMIKACIN KIT?

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

What is the FDA product code for FPR AMIKACIN KIT?

The FDA product code for FPR AMIKACIN KIT is KLQ.

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Other records listing Colony Laboratories, Inc. 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.

K894523FPR GENTAMICIN KITK894524FPR GENTAMICIN CALIBRATOR KITK894518FPR AMIKACIN CALIBRATOR KITK894528FPR PHENYTOIN CALIBRATOR KITK894527FPR PHENYTOIN KITK894521FPR DIGOXIN KIT

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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.K852317COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATORRoche Diagnostic Systems, 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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