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FDA 510(k)

BACT/ALERT 3D MICROBIAL DETECTION SYSTEM

K-Number: K981736 · 1998-07-24

ApplicantOrganon Teknika Corp.
Decision Date1998-07-24
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACT/ALERT 3D MICROBIAL DETECTION SYSTEM 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 1998-07-24 under 510(k) number K981736. 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 BACT/ALERT 3D MICROBIAL DETECTION SYSTEM?

BACT/ALERT 3D MICROBIAL DETECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-24. The listed applicant is Organon Teknika Corp.. The 510(k) number is K981736.

When did BACT/ALERT 3D MICROBIAL DETECTION SYSTEM receive FDA 510(k) clearance?

BACT/ALERT 3D MICROBIAL DETECTION SYSTEM received FDA 510(k) clearance on 1998-07-24, under 510(k) number K981736.

Who is the listed applicant for BACT/ALERT 3D MICROBIAL DETECTION SYSTEM?

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 BACT/ALERT 3D MICROBIAL DETECTION SYSTEM?

The FDA product code for BACT/ALERT 3D MICROBIAL DETECTION SYSTEM 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 SAK993576BACT/ALERT MP PROCESS BOTTLE

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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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