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FDA 510(k)

COLOSCREEN-ES

K-Number: K980671 · 1998-05-12

ApplicantHelena Laboratories
Decision Date1998-05-12
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COLOSCREEN-ES is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1998-05-12 under 510(k) number K980671. 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-ES?

COLOSCREEN-ES is a medical device that received FDA 510(k) clearance on 1998-05-12. The listed applicant is Helena Laboratories. The 510(k) number is K980671.

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

COLOSCREEN-ES received FDA 510(k) clearance on 1998-05-12, under 510(k) number K980671.

Who is the listed applicant for COLOSCREEN-ES?

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-ES?

The FDA product code for COLOSCREEN-ES 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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