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FDA 510(k)

READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS

K-Number: K925859 · 1993-07-08

ApplicantAlamar Biosciences, Inc.
Decision Date1993-07-08
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS 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 1993-07-08 under 510(k) number K925859. The device is classified under product code LRG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS?

READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS is a medical device that received FDA 510(k) clearance on 1993-07-08. The listed applicant is Alamar Biosciences, Inc.. The 510(k) number is K925859.

When did READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS receive FDA 510(k) clearance?

READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS received FDA 510(k) clearance on 1993-07-08, under 510(k) number K925859.

Who is the listed applicant for READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS?

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 READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS?

The FDA product code for READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS is LRG.

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.

K943756MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCEK944723ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATIONK933885ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANELK930478READAR

Related Devices (Code: LRG)

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.

K191918Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK191914Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher ScientificK110583SENSITITRE OPTIREADTrek Diagnostic Systems, Ltd.K103532AUTOREADER 2Trek Diagnostic SystemsK111677MICROSCAN(R) MICROSTREP PLUS(R)Siemens Healthcare Diagnostics, Inc.K111205MICROSCAN (R) MICROSTREP PLUS (R) PANELSSiemens Healthcare Diagnostics, Inc.

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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