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FDA 510(k)

MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE

K-Number: K943756 · 1995-02-17

ApplicantAlamar Biosciences, Inc.
Decision Date1995-02-17
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE 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 1995-02-17 under 510(k) number K943756. 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 MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE?

MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE is a medical device that received FDA 510(k) clearance on 1995-02-17. The listed applicant is Alamar Biosciences, Inc.. The 510(k) number is K943756.

When did MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE receive FDA 510(k) clearance?

MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE received FDA 510(k) clearance on 1995-02-17, under 510(k) number K943756.

Who is the listed applicant for MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE?

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 MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE?

The FDA product code for MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE is JWY.

Related Clinical Trials

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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.

K944723ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATIONK933885ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANELK930478READARK925859READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS

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Official Source

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