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CIBIO Test DOA13PC

by Co-Innovation Biotech Co., Ltd

CIBIO Test DOA13PC is a Class II device made by Co-Innovation Biotech Co., Ltd, cleared under FDA 510(k) K153050 on 26 Apr 2016 and listed in FDA GUDID since 27 Oct 2016 (UDI-DI 06970429841321), 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

510(k) K153050

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970429841321 UDI-DI Date27 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK153050 Date26 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153050 decided 26 Apr 2016 Active
  • FDA GUDID UDI-DI 06970429841321 listed 27 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153050
  2. Listed FDA GUDID 06970429841321

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CIBIO Test
Generic name
Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Model / reference
DOA13PC
Primary DI / UDI-DI
06970429841321
510(k) Number
FDA product code
LFG, DKZ, DIS, DJG, JXM, DIO, DJC, DNK, DJR, LCM, LDJ
GMDN term
Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3910, 862.3100, 862.3150, 862.3650, 862.3170, 862.3250, 862.3610, 862.3640, 862.3620, 862.3870
GUDID distribution status
In Commercial Distribution

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Cleared under the same submission (K153050)

and 8 more cleared under K153050

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Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)