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FDA 510(k)

BLOOD AGAR(TSA W/5% SHEEP BLOOD)

K-Number: K830078 · 1983-02-09

ApplicantbioMerieux, Inc.
Decision Date1983-02-09
Product CodeKZI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BLOOD AGAR(TSA W/5% SHEEP BLOOD) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 1983-02-09 under 510(k) number K830078. The device is classified under product code KZI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD AGAR(TSA W/5% SHEEP BLOOD)?

BLOOD AGAR(TSA W/5% SHEEP BLOOD) is a medical device that received FDA 510(k) clearance on 1983-02-09. The listed applicant is bioMerieux, Inc.. The 510(k) number is K830078.

When did BLOOD AGAR(TSA W/5% SHEEP BLOOD) receive FDA 510(k) clearance?

BLOOD AGAR(TSA W/5% SHEEP BLOOD) received FDA 510(k) clearance on 1983-02-09, under 510(k) number K830078.

Who is the listed applicant for BLOOD AGAR(TSA W/5% SHEEP BLOOD)?

The FDA 510(k) record lists bioMerieux, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOOD AGAR(TSA W/5% SHEEP BLOOD)?

The FDA product code for BLOOD AGAR(TSA W/5% SHEEP BLOOD) is KZI.

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Related Devices (Code: KZI)

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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