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FDA 510(k)

CYTOSMEAR BRUSH

K-Number: K904160 · 1990-11-02

ApplicantBrooke Intl.
Decision Date1990-11-02
Product CodeHHI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CYTOSMEAR BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Brooke Intl.. It received FDA 510(k) clearance on 1990-11-02 under 510(k) number K904160. The device is classified under product code HHI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOSMEAR BRUSH?

CYTOSMEAR BRUSH is a medical device that received FDA 510(k) clearance on 1990-11-02. The listed applicant is Brooke Intl.. The 510(k) number is K904160.

When did CYTOSMEAR BRUSH receive FDA 510(k) clearance?

CYTOSMEAR BRUSH received FDA 510(k) clearance on 1990-11-02, under 510(k) number K904160.

Who is the listed applicant for CYTOSMEAR BRUSH?

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

What is the FDA product code for CYTOSMEAR BRUSH?

The FDA product code for CYTOSMEAR BRUSH is HHI.

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Related Devices (Code: HHI)

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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