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FDA 510(k)

BACT/ALERT FN

K-Number: K992432 · 1999-09-24

ApplicantOrganon Teknika Corp.
Decision Date1999-09-24
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACT/ALERT FN 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 1999-09-24 under 510(k) number K992432. 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 FN?

BACT/ALERT FN is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Organon Teknika Corp.. The 510(k) number is K992432.

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

BACT/ALERT FN received FDA 510(k) clearance on 1999-09-24, under 510(k) number K992432.

Who is the listed applicant for BACT/ALERT FN?

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 FN?

The FDA product code for BACT/ALERT FN 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.

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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.

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