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Matrix Plus Cholesterol, Level F 9556

by Verichem Laboratories, Inc.

Matrix Plus Cholesterol, Level F 9556 is a Class II device made by Verichem Laboratories, Inc., cleared under FDA 510(k) K901113 on 29 Mar 1990 and listed in FDA GUDID since 16 Jan 2018 (UDI-DI 00852553007223), 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) K901113

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 Number00852553007223 UDI-DI Date16 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK901113 Date29 Mar 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K901113 decided 29 Mar 1990 Active
  • FDA GUDID UDI-DI 00852553007223 listed 16 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K901113
  2. Listed FDA GUDID 00852553007223

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Matrix Plus Cholesterol, Level F
Generic name
Total cholesterol lipid IVD, calibrator
Model / reference
9556
Primary DI / UDI-DI
00852553007223
510(k) Number
FDA product code
JIS
GMDN term
Total cholesterol lipid IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JIS (Calibrator, Primary).

Other devices from Verichem Laboratories, Inc.

See all devices from Verichem Laboratories, Inc. →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)