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FDA 510(k)

MB/BACT BLOOD CULTURE BOTTLE

K-Number: K982263 · 1998-08-18

ApplicantOrganon Teknika Corp.
Decision Date1998-08-18
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MB/BACT BLOOD 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 1998-08-18 under 510(k) number K982263. 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 MB/BACT BLOOD CULTURE BOTTLE?

MB/BACT BLOOD CULTURE BOTTLE is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Organon Teknika Corp.. The 510(k) number is K982263.

When did MB/BACT BLOOD CULTURE BOTTLE receive FDA 510(k) clearance?

MB/BACT BLOOD CULTURE BOTTLE received FDA 510(k) clearance on 1998-08-18, under 510(k) number K982263.

Who is the listed applicant for MB/BACT BLOOD 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 MB/BACT BLOOD CULTURE BOTTLE?

The FDA product code for MB/BACT BLOOD 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 SAK993576BACT/ALERT MP PROCESS BOTTLE

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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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