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FDA 510(k)

BACTALERT FA

K-Number: K992400 · 1999-09-03

ApplicantOrganon Teknika Corp.
Decision Date1999-09-03
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTALERT FA is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1999-09-03 under 510(k) number K992400. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACTALERT FA?

BACTALERT FA is a medical device that received FDA 510(k) clearance on 1999-09-03. The listed applicant is Organon Teknika Corp.. The 510(k) number is K992400.

When did BACTALERT FA receive FDA 510(k) clearance?

BACTALERT FA received FDA 510(k) clearance on 1999-09-03, under 510(k) number K992400.

Who is the listed applicant for BACTALERT FA?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BACTALERT FA?

The FDA product code for BACTALERT FA is MDB.

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Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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Related Devices (Code: MDB)

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.

K260213BD BACTEC FXI Culture SystemBD Diagnostic SystemsK222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and CompanyK222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and CompanyK190405BACT/ALERT MP Reagent SystembioMerieux, Inc.K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic VialBecton, Dickinson and Company

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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