OC-Auto SENSOR io iFOB Test
K-Number: K191147 · 2020-01-02
ApplicantEiken Chemical Co., Ltd.
Decision Date2020-01-02
Product CodeOOX
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
OC-Auto SENSOR io iFOB Test is a medical device manufactured by Eiken Chemical Co., Ltd.. It received FDA 510(k) clearance on 2020-01-02 under approval 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. It is manufactured by Eiken Chemical Co., Ltd.. The 510(k) number is K191147.
When was OC-Auto SENSOR io iFOB Test approved by the FDA?
OC-Auto SENSOR io iFOB Test received FDA 510(k) clearance on 2020-01-02, under approval number K191147.
What company makes OC-Auto SENSOR io iFOB Test?
OC-Auto SENSOR io iFOB Test is manufactured by Eiken Chemical Co., Ltd..
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)
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.