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FDA 510(k)

ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL

K-Number: K933885 · 1993-11-16

ApplicantAlamar Biosciences, Inc.
Decision Date1993-11-16
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 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 1993-11-16 under 510(k) number K933885. 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 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL?

ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL is a medical device that received FDA 510(k) clearance on 1993-11-16. The listed applicant is Alamar Biosciences, Inc.. The 510(k) number is K933885.

When did ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL receive FDA 510(k) clearance?

ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL received FDA 510(k) clearance on 1993-11-16, under 510(k) number K933885.

Who is the listed applicant for ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL?

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 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL?

The FDA product code for ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL 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 RESISTANCEK944723ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATIONK930478READARK925859READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS

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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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