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FDA 510(k)

READER

K-Number: K926248 · 1994-05-17

ApplicantAlamar Biosciences Laboratory, Inc.
Decision Date1994-05-17
Product CodeLRH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

READER 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 1994-05-17 under 510(k) number K926248. The device is classified under product code LRH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the READER?

READER is a medical device that received FDA 510(k) clearance on 1994-05-17. The listed applicant is Alamar Biosciences Laboratory, Inc.. The 510(k) number is K926248.

When did READER receive FDA 510(k) clearance?

READER received FDA 510(k) clearance on 1994-05-17, under 510(k) number K926248.

Who is the listed applicant for READER?

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 READER?

The FDA product code for READER is LRH.

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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.

K941425ALAMAR ANTIBIOTIC SUSCEPTIBILITYK926002ALAMAR BACTERIAL IDENTIFICATION TEST PANELK925951READARK930469ANTIMICROBIAL SUSCEPTIBILITY TEST PANELK930055ANTIMICROBIAL SUSCEPTIBILITY TEST PANELK924500ANTIMICROBIAL SUSCEPTIBILITY TEST

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Related Devices (Code: LRH)

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.

K962609GRAM NEGATIVE IDENTIFICATION PLUS CARDBiomerieux Vitek, Inc.K961042MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANELDade Microscan, Inc.K920225AUTOSCEPTOR IDENTIFICATION SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic

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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