FDA 510(k)

CLEARENE, CLEARING AGENT

K-Number: K855109 · 1986-01-07

ApplicantSurgipath Medical Industries, Inc.

Decision Date1986-01-07

Product CodeKEM

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

CLEARENE, CLEARING AGENT is the device name listed in this FDA 510(k) record. The listed applicant is Surgipath Medical Industries, Inc.. It received FDA 510(k) clearance on 1986-01-07 under 510(k) number K855109. The device is classified under product code KEM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARENE, CLEARING AGENT?

CLEARENE, CLEARING AGENT is a medical device that received FDA 510(k) clearance on 1986-01-07. The listed applicant is Surgipath Medical Industries, Inc.. The 510(k) number is K855109.

When did CLEARENE, CLEARING AGENT receive FDA 510(k) clearance?

CLEARENE, CLEARING AGENT received FDA 510(k) clearance on 1986-01-07, under 510(k) number K855109.

Who is the listed applicant for CLEARENE, CLEARING AGENT?

The FDA 510(k) record lists Surgipath Medical Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARENE, CLEARING AGENT?

The FDA product code for CLEARENE, CLEARING AGENT is KEM.

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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.