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FDA 510(k)

OraCure

K-Number: K183436 · 2019-09-18

ApplicantTbm Corporation
Decision Date2019-09-18
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

OraCure is a medical device manufactured by Tbm Corporation. It received FDA 510(k) clearance on 2019-09-18 under approval number K183436. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OraCure?

OraCure is a medical device that received FDA 510(k) clearance on 2019-09-18. It is manufactured by Tbm Corporation. The 510(k) number is K183436.

When was OraCure approved by the FDA?

OraCure received FDA 510(k) clearance on 2019-09-18, under approval number K183436.

What company makes OraCure?

OraCure is manufactured by Tbm Corporation.

What is the FDA product code for OraCure?

The FDA product code for OraCure is OLR.

Other Devices by Tbm Corporation

K211851Ora-Aid

Related Devices (Code: OLR)

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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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