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FDA 510(k)

MACRO-VUE CARD TEST, AMIKACIN

K-Number: K821771 · 1982-06-25

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1982-06-25
Product CodeKLQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MACRO-VUE CARD TEST, AMIKACIN is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K821771. 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 MACRO-VUE CARD TEST, AMIKACIN?

MACRO-VUE CARD TEST, AMIKACIN is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K821771.

When did MACRO-VUE CARD TEST, AMIKACIN receive FDA 510(k) clearance?

MACRO-VUE CARD TEST, AMIKACIN received FDA 510(k) clearance on 1982-06-25, under 510(k) number K821771.

Who is the listed applicant for MACRO-VUE CARD TEST, AMIKACIN?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MACRO-VUE CARD TEST, AMIKACIN?

The FDA product code for MACRO-VUE CARD TEST, AMIKACIN is KLQ.

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