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FDA 510(k)

ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST

K-Number: K903556 · 1990-10-02

ApplicantGen-Probe, Inc.
Decision Date1990-10-02
Product CodeMDE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST 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 1990-10-02 under 510(k) number K903556. The device is classified under product code MDE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST?

ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST is a medical device that received FDA 510(k) clearance on 1990-10-02. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K903556.

When did ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST receive FDA 510(k) clearance?

ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST received FDA 510(k) clearance on 1990-10-02, under 510(k) number K903556.

Who is the listed applicant for ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST?

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 CRYPTOCOCCUS NEOFORMANS CULTURE TEST?

The FDA product code for ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST is MDE.

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Other records listing Gen-Probe, Inc. 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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