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FDA 510(k)

ANTIMICROBIAL AMIKACIN

K-Number: K911303 · 1991-04-18

ApplicantAlamar Biosciences Laboratory, Inc.
Decision Date1991-04-18
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTIMICROBIAL AMIKACIN is the device name listed in this FDA 510(k) record. The listed applicant is Alamar Biosciences Laboratory, Inc.. It received FDA 510(k) clearance on 1991-04-18 under 510(k) number K911303. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIMICROBIAL AMIKACIN?

ANTIMICROBIAL AMIKACIN is a medical device that received FDA 510(k) clearance on 1991-04-18. The listed applicant is Alamar Biosciences Laboratory, Inc.. The 510(k) number is K911303.

When did ANTIMICROBIAL AMIKACIN receive FDA 510(k) clearance?

ANTIMICROBIAL AMIKACIN received FDA 510(k) clearance on 1991-04-18, under 510(k) number K911303.

Who is the listed applicant for ANTIMICROBIAL AMIKACIN?

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

What is the FDA product code for ANTIMICROBIAL AMIKACIN?

The FDA product code for ANTIMICROBIAL AMIKACIN is JWY.

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Other records listing Alamar Biosciences Laboratory, 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.

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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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