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co-innovation DOA14PC

by Co-Innovation Biotech Co., Ltd

co-innovation DOA14PC 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 19 Jun 2017 (UDI-DI 06970429841406), 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 Number06970429841406 UDI-DI Date19 Jun 2017ListedStatusListed 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 06970429841406 listed 19 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153050
  2. Listed FDA GUDID 06970429841406

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
co-innovation
Generic name
Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Model / reference
DOA14PC
Primary DI / UDI-DI
06970429841406
510(k) Number
FDA product code
JXN, LDJ, LFG, LCM, DNK, DJC, DIO, JXM, DJG, DIS, DKZ
GMDN term
Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
862.3700, 862.3870, 862.3910, 862.3640, 862.3610, 862.3250, 862.3170, 862.3650, 862.3150, 862.3100
GUDID distribution status
In Commercial Distribution

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Cleared under the same submission (K153050)

and 8 more cleared under K153050

Similar devices

Other devices filed under FDA product code JXN (Enzyme Immunoassay, Propoxyphene).

Other devices from Co-Innovation Biotech Co., Ltd

See all devices from Co-Innovation Biotech Co., Ltd →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)