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FDA 510(k)

ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.

K-Number: K901397 · 1990-06-20

ApplicantGen-Probe, Inc.
Decision Date1990-06-20
Product CodeMCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. 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 1990-06-20 under 510(k) number K901397. The device is classified under product code MCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.?

ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. is a medical device that received FDA 510(k) clearance on 1990-06-20. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K901397.

When did ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. receive FDA 510(k) clearance?

ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. received FDA 510(k) clearance on 1990-06-20, under 510(k) number K901397.

Who is the listed applicant for ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.?

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 LISTERIA MONOCYTOGENES CULTURE CONFIRMA.?

The FDA product code for ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. is MCC.

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Other records listing Gen-Probe, Inc. as applicant

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Related Devices (Code: MCC)

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.

K897079ACCUPROBE HAEOMPHILUS INFLUENZAE CULTUREGen-Probe, Inc.

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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