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Lipoprotein Verifier Kit 9570

by Verichem Laboratories, Inc.

Lipoprotein Verifier Kit 9570 is a Class II device made by Verichem Laboratories, Inc., cleared under FDA 510(k) K924904 on 13 Jan 1993 and listed in FDA GUDID since 29 Nov 2016 (UDI-DI 00852553007124), 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) K924904

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 Number00852553007124 UDI-DI Date29 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK924904 Date13 Jan 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K924904 decided 13 Jan 1993 Active
  • FDA GUDID UDI-DI 00852553007124 listed 29 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K924904
  2. Listed FDA GUDID 00852553007124

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lipoprotein Verifier Kit
Generic name
Total lipoprotein IVD, calibrator
Model / reference
9570
Primary DI / UDI-DI
00852553007124
510(k) Number
FDA product code
JIS
GMDN term
Total lipoprotein 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

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