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FDA 510(k)

ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION

K-Number: K944723 · 1994-10-21

ApplicantAlamar Biosciences, Inc.
Decision Date1994-10-21
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Alamar Biosciences, Inc.. It received FDA 510(k) clearance on 1994-10-21 under 510(k) number K944723. 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 SUSCEPTIBILITY TEST PANEL MODIFICATION?

ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-10-21. The listed applicant is Alamar Biosciences, Inc.. The 510(k) number is K944723.

When did ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION receive FDA 510(k) clearance?

ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION received FDA 510(k) clearance on 1994-10-21, under 510(k) number K944723.

Who is the listed applicant for ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION?

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

What is the FDA product code for ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION?

The FDA product code for ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION is JWY.

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Other records listing Alamar Biosciences, 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.

K943756MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCEK933885ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANELK930478READARK925859READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS

Related Devices (Code: JWY)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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