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Opiate DAU Control, Level 2 Control 0028

by Lin-Zhi International, Inc.

Opiate DAU Control, Level 2 Control 0028 is a Class I device made by Lin-Zhi International, Inc., cleared under FDA 510(k) K020769 on 3 Apr 2002 and listed in FDA GUDID since 5 Jul 2016 (UDI-DI B07600280), active as of 23 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 23 Oct 2026

Documents

510(k) K020769

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB07600280 UDI-DI Date5 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020769 Date3 Apr 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020769 decided 3 Apr 2002 Active
  • FDA GUDID UDI-DI B07600280 listed 5 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020769
  2. Listed FDA GUDID B07600280

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Opiate DAU Control, Level 2 Control
Generic name
Opiate/opiate metabolite IVD, control
Model / Ref / Catalog
0028
Description
5mL/bottle. Concentration: 375 ng/mL of Morphine.
Primary DI / UDI-DI
B07600280
510(k) Number
FDA product code
LAS
GMDN term
Opiate/opiate metabolite IVD, control
Device class
Class I
Regulation number
862.3280
GUDID distribution status
In Commercial Distribution

Related devices

Category: Opiate/opiate metabolite IVD, control

Cleared under the same submission (K020769)

and 8 more cleared under K020769

Similar devices

Other devices filed under FDA product code LAS (Drug Specific Control Materials).

Other devices from Lin-Zhi International, Inc.

See all devices from Lin-Zhi International, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)