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FDA 510(k)

BACT/ALERT FAN CULTURE BOTTLE

K-Number: K944594 · 1995-02-17

ApplicantOrganon Teknika Corp.
Decision Date1995-02-17
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACT/ALERT FAN CULTURE BOTTLE 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 1995-02-17 under 510(k) number K944594. 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 FAN CULTURE BOTTLE?

BACT/ALERT FAN CULTURE BOTTLE is a medical device that received FDA 510(k) clearance on 1995-02-17. The listed applicant is Organon Teknika Corp.. The 510(k) number is K944594.

When did BACT/ALERT FAN CULTURE BOTTLE receive FDA 510(k) clearance?

BACT/ALERT FAN CULTURE BOTTLE received FDA 510(k) clearance on 1995-02-17, under 510(k) number K944594.

Who is the listed applicant for BACT/ALERT FAN CULTURE BOTTLE?

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 FAN CULTURE BOTTLE?

The FDA product code for BACT/ALERT FAN CULTURE BOTTLE 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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