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FDA 510(k)

AMIKACIN REAGENT TEST KIT

K-Number: K840647 · 1984-04-02

ApplicantBeckman Instruments, Inc.
Decision Date1984-04-02
Product CodeLDN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMIKACIN REAGENT TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1984-04-02 under 510(k) number K840647. The device is classified under product code LDN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIKACIN REAGENT TEST KIT?

AMIKACIN REAGENT TEST KIT is a medical device that received FDA 510(k) clearance on 1984-04-02. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K840647.

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

AMIKACIN REAGENT TEST KIT received FDA 510(k) clearance on 1984-04-02, under 510(k) number K840647.

Who is the listed applicant for AMIKACIN REAGENT TEST KIT?

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

What is the FDA product code for AMIKACIN REAGENT TEST KIT?

The FDA product code for AMIKACIN REAGENT TEST KIT is LDN.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: LDN)

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.

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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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