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FDA 510(k)

OC-SENSOR DIANA IFOB TEST

K-Number: K092330 · 2010-01-08

ApplicantPolymedco Cancer Diagnostics, LLC
Decision Date2010-01-08
Product CodeOOX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OC-SENSOR DIANA IFOB TEST is the device name listed in this FDA 510(k) record. The listed applicant is Polymedco Cancer Diagnostics, LLC. It received FDA 510(k) clearance on 2010-01-08 under 510(k) number K092330. 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 OC-SENSOR DIANA IFOB TEST?

OC-SENSOR DIANA IFOB TEST is a medical device that received FDA 510(k) clearance on 2010-01-08. The listed applicant is Polymedco Cancer Diagnostics, LLC. The 510(k) number is K092330.

When did OC-SENSOR DIANA IFOB TEST receive FDA 510(k) clearance?

OC-SENSOR DIANA IFOB TEST received FDA 510(k) clearance on 2010-01-08, under 510(k) number K092330.

Who is the listed applicant for OC-SENSOR DIANA IFOB TEST?

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

What is the FDA product code for OC-SENSOR DIANA IFOB TEST?

The FDA product code for OC-SENSOR DIANA IFOB TEST is OOX.

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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.,K041408POLYMEDCO OC AUTO MICRO 80 FOB TESTPolymedco, Inc.

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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