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FDA 510(k)

BACT/ALERT CULTURE BOTTLES

K-Number: K973305 · 1997-11-17

ApplicantOrganon Teknika Corp.
Decision Date1997-11-17
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACT/ALERT CULTURE BOTTLES 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 1997-11-17 under 510(k) number K973305. 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 CULTURE BOTTLES?

BACT/ALERT CULTURE BOTTLES is a medical device that received FDA 510(k) clearance on 1997-11-17. The listed applicant is Organon Teknika Corp.. The 510(k) number is K973305.

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

BACT/ALERT CULTURE BOTTLES received FDA 510(k) clearance on 1997-11-17, under 510(k) number K973305.

Who is the listed applicant for BACT/ALERT CULTURE BOTTLES?

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 CULTURE BOTTLES?

The FDA product code for BACT/ALERT CULTURE BOTTLES 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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