FDA 510(k)

Green Card Bowie-Dick Test (BD115)

K-Number: K250172 · 2025-02-20

ApplicantSteritec Products, Inc. (A Getinge Company)

Decision Date2025-02-20

Product CodeJOJ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Green Card Bowie-Dick Test (BD115) is a medical device manufactured by Steritec Products, Inc. (A Getinge Company). It received FDA 510(k) clearance on 2025-02-20 under approval number K250172. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Green Card Bowie-Dick Test (BD115)?

Green Card Bowie-Dick Test (BD115) is a medical device that received FDA 510(k) clearance on 2025-02-20. It is manufactured by Steritec Products, Inc. (A Getinge Company). The 510(k) number is K250172.

When was Green Card Bowie-Dick Test (BD115) approved by the FDA?

Green Card Bowie-Dick Test (BD115) received FDA 510(k) clearance on 2025-02-20, under approval number K250172.

What company makes Green Card Bowie-Dick Test (BD115)?

Green Card Bowie-Dick Test (BD115) is manufactured by Steritec Products, Inc. (A Getinge Company).

What is the FDA product code for Green Card Bowie-Dick Test (BD115)?

The FDA product code for Green Card Bowie-Dick Test (BD115) is JOJ.

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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.