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FDA 510(k)

ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.

K-Number: K904047 · 1990-10-02

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

Device Summary

ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. 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 K904047. The device is classified under product code MDF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.?

ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. 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 K904047.

When did ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. receive FDA 510(k) clearance?

ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. received FDA 510(k) clearance on 1990-10-02, under 510(k) number K904047.

Who is the listed applicant for ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.?

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 COCCIDIOIDES IMMITIS CULTURE CONFIRM.?

The FDA product code for ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. is MDF.

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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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