FDA 510(k)

OC-Auto SENSOR io iFOB Test

K-Number: K191147 · 2020-01-02

Decision Date2020-01-02

Product CodeOOX

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

OC-Auto SENSOR io iFOB Test is the device name listed in this FDA 510(k) record. The listed applicant is Eiken Chemical Co., Ltd.. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K191147. 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-Auto SENSOR io iFOB Test?

OC-Auto SENSOR io iFOB Test is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Eiken Chemical Co., Ltd.. The 510(k) number is K191147.

When did OC-Auto SENSOR io iFOB Test receive FDA 510(k) clearance?

OC-Auto SENSOR io iFOB Test received FDA 510(k) clearance on 2020-01-02, under 510(k) number K191147.

Who is the listed applicant for OC-Auto SENSOR io iFOB Test?

The FDA 510(k) record lists Eiken Chemical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OC-Auto SENSOR io iFOB Test?

The FDA product code for OC-Auto SENSOR io iFOB Test is OOX.

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.K163225AFIAS iFOB with AFIAS-50Immunostics Inc.,

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.