FDA 510(k)

BACT/ALERT 120

K-Number: K934593 · 1994-02-09

Decision Date1994-02-09

Product CodeMDB

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BACT/ALERT 120 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 1994-02-09 under 510(k) number K934593. 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 120?

BACT/ALERT 120 is a medical device that received FDA 510(k) clearance on 1994-02-09. The listed applicant is Organon Teknika Corp.. The 510(k) number is K934593.

When did BACT/ALERT 120 receive FDA 510(k) clearance?

BACT/ALERT 120 received FDA 510(k) clearance on 1994-02-09, under 510(k) number K934593.

Who is the listed applicant for BACT/ALERT 120?

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 120?

The FDA product code for BACT/ALERT 120 is MDB.

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Other records listing Organon Teknika Corp. as applicant

K003104BACT/ALERT CSR K000492MDA D-DIMER K000378BACT/ALERT MB CULTURE BOTTLE K994343BACT/ALERT SV K993423BACT/ALERT SA K993421BACT/ALERT SN

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Related Devices (Code: MDB)

K260213BD BACTEC FXI Culture SystemBD Diagnostic Systems K222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and Company K222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and Company K190405BACT/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.