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MassTrak™ 186002891

by Waters Technologies Corporation

MassTrak™ 186002891 is a Class II device made by Waters Technologies Corporation, cleared under FDA 510(k) K063868 on 25 May 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00816776020001), 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) K063868

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 Number00816776020001 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063868 Date25 May 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063868 decided 25 May 2007 Active
  • FDA GUDID UDI-DI 00816776020001 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063868
  2. Listed FDA GUDID 00816776020001

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MassTrak™
Generic name
Tacrolimus therapeutic drug monitoring IVD, control
Model / Ref / Catalog
186002891
Primary DI / UDI-DI
00816776020001
510(k) Number
FDA product code
MLM, JJX, JIT
GMDN term
Tacrolimus therapeutic drug monitoring IVD, control
Device class
Class II
Regulation number
862.1678, 862.1660, 862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tacrolimus therapeutic drug monitoring IVD, calibratorTacrolimus therapeutic drug monitoring IVD, control

Similar devices

Other devices filed under FDA product code MLM (Enzyme Immunoassay, Tracrolimus).

Other devices from Waters Technologies Corporation

See all devices from Waters Technologies Corporation →

Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)