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FDA 510(k)

ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION

K-Number: K895103 · 1989-11-29

ApplicantGen-Probe, Inc.
Decision Date1989-11-29
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe, Inc.. It received FDA 510(k) clearance on 1989-11-29 under 510(k) number K895103. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION?

ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION is a medical device that received FDA 510(k) clearance on 1989-11-29. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K895103.

When did ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION receive FDA 510(k) clearance?

ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION received FDA 510(k) clearance on 1989-11-29, under 510(k) number K895103.

Who is the listed applicant for ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION?

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

What is the FDA product code for ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION?

The FDA product code for ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATION is GTZ.

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Related Devices (Code: GTZ)

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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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