FDA 510(k)

BACT/ALERT SA

K-Number: K993423 · 1999-12-15

Decision Date1999-12-15

Product CodeMDB

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BACT/ALERT SA 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 1999-12-15 under 510(k) number K993423. 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 SA?

BACT/ALERT SA is a medical device that received FDA 510(k) clearance on 1999-12-15. The listed applicant is Organon Teknika Corp.. The 510(k) number is K993423.

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

BACT/ALERT SA received FDA 510(k) clearance on 1999-12-15, under 510(k) number K993423.

Who is the listed applicant for BACT/ALERT SA?

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 SA?

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

Related Clinical Trials

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.

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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 K993576BACT/ALERT MP PROCESS BOTTLE K993421BACT/ALERT SN

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Related Devices (Code: MDB)

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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.