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FDA 510(k)

POLYMEDCO OC LIGHT FOBT TEST

K-Number: K041297 · 2004-08-12

ApplicantPolymedco, Inc.
Decision Date2004-08-12
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

POLYMEDCO OC LIGHT FOBT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Polymedco, Inc.. It received FDA 510(k) clearance on 2004-08-12 under 510(k) number K041297. 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 POLYMEDCO OC LIGHT FOBT TEST?

POLYMEDCO OC LIGHT FOBT TEST is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Polymedco, Inc.. The 510(k) number is K041297.

When did POLYMEDCO OC LIGHT FOBT TEST receive FDA 510(k) clearance?

POLYMEDCO OC LIGHT FOBT TEST received FDA 510(k) clearance on 2004-08-12, under 510(k) number K041297.

Who is the listed applicant for POLYMEDCO OC LIGHT FOBT TEST?

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

What is the FDA product code for POLYMEDCO OC LIGHT FOBT TEST?

The FDA product code for POLYMEDCO OC LIGHT FOBT TEST is KHE.

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Related Devices (Code: KHE)

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

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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