Rapid Response COC-1C3-40

Rapid Response COC-1C3-40 is a Class II device made by BTNX Inc, cleared under FDA 510(k) K121065 on 24 May 2013 and listed in FDA GUDID since 24 Oct 2016 (UDI-DI 00722066000533), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00722066000533 UDI-DI	Date24 Oct 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK121065	Date24 May 2013Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00722066000533
FDA 510(k) database 510(k) number K121065

Across registries

2 registries list this device

FDA 510(k) K121065 decided 24 May 2013 Active
FDA GUDID UDI-DI 00722066000533 listed 24 Oct 2016 Listed

Timeline

2 dated events

24 May 2013 Cleared FDA 510(k) K121065
24 Oct 2016 Listed FDA GUDID 00722066000533

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Rapid Response
Generic name: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog: COC-1C3-40

Primary DI / UDI-DI: 00722066000533
510(k) Number: K121065
FDA product code: DIO
GMDN term: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Device class: Class II
Regulation number: 862.3250
GUDID distribution status: In Commercial Distribution

Similar devices in this category

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Other devices from BTNX Inc

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Properties

Single use
Prescription use
Convenience kit
Lot / batch number
Expiration date

Other properties (10, all answered No)