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FDA 510(k)

BAC-T-SCREEN

K-Number: K924218 · 1993-02-03

ApplicantBiomerieux Vitek, Inc.
Decision Date1993-02-03
Product CodeJXA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BAC-T-SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1993-02-03 under 510(k) number K924218. The device is classified under product code JXA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAC-T-SCREEN?

BAC-T-SCREEN is a medical device that received FDA 510(k) clearance on 1993-02-03. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K924218.

When did BAC-T-SCREEN receive FDA 510(k) clearance?

BAC-T-SCREEN received FDA 510(k) clearance on 1993-02-03, under 510(k) number K924218.

Who is the listed applicant for BAC-T-SCREEN?

The FDA 510(k) record lists Biomerieux Vitek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAC-T-SCREEN?

The FDA product code for BAC-T-SCREEN is JXA.

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Other records listing Biomerieux Vitek, Inc. as applicant

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Related Devices (Code: JXA)

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.

K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)OsmetechK981084URISCREENDiatech Diagnostics,Inc.K972676URINE SCREENING DEVICECombact Diagnostic Systems , Ltd.K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)Izon Business Products, Inc.K950246MULTIPLE (IZON URINE COLLECTION KIT)Izon Business Products, 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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