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FDA 510(k)

ALAMAR ANTIBIOTIC SUSCEPTIBILITY

K-Number: K941425 · 1994-12-15

ApplicantAlamar Biosciences Laboratory, Inc.
Decision Date1994-12-15
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ALAMAR ANTIBIOTIC SUSCEPTIBILITY 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 1994-12-15 under 510(k) number K941425. 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 ALAMAR ANTIBIOTIC SUSCEPTIBILITY?

ALAMAR ANTIBIOTIC SUSCEPTIBILITY is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Alamar Biosciences Laboratory, Inc.. The 510(k) number is K941425.

When did ALAMAR ANTIBIOTIC SUSCEPTIBILITY receive FDA 510(k) clearance?

ALAMAR ANTIBIOTIC SUSCEPTIBILITY received FDA 510(k) clearance on 1994-12-15, under 510(k) number K941425.

Who is the listed applicant for ALAMAR ANTIBIOTIC SUSCEPTIBILITY?

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 ALAMAR ANTIBIOTIC SUSCEPTIBILITY?

The FDA product code for ALAMAR ANTIBIOTIC SUSCEPTIBILITY is LRG.

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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.

K926248READERK926002ALAMAR BACTERIAL IDENTIFICATION TEST PANELK925951READARK930469ANTIMICROBIAL SUSCEPTIBILITY TEST PANELK930055ANTIMICROBIAL SUSCEPTIBILITY TEST PANELK924500ANTIMICROBIAL SUSCEPTIBILITY TEST

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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

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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