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FDA 510(k)

POLYMEDCO OC AUTO MICRO 80 FOB TEST

K-Number: K041408 · 2004-10-21

ApplicantPolymedco, Inc.
Decision Date2004-10-21
Product CodeOOX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

POLYMEDCO OC AUTO MICRO 80 FOB 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 2004-10-21 under 510(k) number K041408. The device is classified under product code OOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYMEDCO OC AUTO MICRO 80 FOB TEST?

POLYMEDCO OC AUTO MICRO 80 FOB TEST is a medical device that received FDA 510(k) clearance on 2004-10-21. The listed applicant is Polymedco, Inc.. The 510(k) number is K041408.

When did POLYMEDCO OC AUTO MICRO 80 FOB TEST receive FDA 510(k) clearance?

POLYMEDCO OC AUTO MICRO 80 FOB TEST received FDA 510(k) clearance on 2004-10-21, under 510(k) number K041408.

Who is the listed applicant for POLYMEDCO OC AUTO MICRO 80 FOB 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 AUTO MICRO 80 FOB TEST?

The FDA product code for POLYMEDCO OC AUTO MICRO 80 FOB TEST is OOX.

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Other records listing Polymedco, Inc. as applicant

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Related Devices (Code: OOX)

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.

K200754Hemosure Accu-Reader A100W.H.P.M., Inc.K191147OC-Auto SENSOR io iFOB TestEiken Chemical Co., Ltd.K163225AFIAS iFOB with AFIAS-50Immunostics Inc.,K092330OC-SENSOR DIANA IFOB TESTPolymedco Cancer Diagnostics, LLC

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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