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FDA 510(k)

COLOSCREEN SELF-TEST

K-Number: K843352 · 1984-12-05

ApplicantHelena Laboratories
Decision Date1984-12-05
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COLOSCREEN SELF-TEST is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1984-12-05 under 510(k) number K843352. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLOSCREEN SELF-TEST?

COLOSCREEN SELF-TEST is a medical device that received FDA 510(k) clearance on 1984-12-05. The listed applicant is Helena Laboratories. The 510(k) number is K843352.

When did COLOSCREEN SELF-TEST receive FDA 510(k) clearance?

COLOSCREEN SELF-TEST received FDA 510(k) clearance on 1984-12-05, under 510(k) number K843352.

Who is the listed applicant for COLOSCREEN SELF-TEST?

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

What is the FDA product code for COLOSCREEN SELF-TEST?

The FDA product code for COLOSCREEN SELF-TEST is KHE.

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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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