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Cholesterol 08057443190

by Roche Diagnostics GmbH

Cholesterol 08057443190 is a Class I device made by Roche Diagnostics GmbH, cleared under FDA 510(k) K031824 on 9 Jul 2003 and listed in FDA GUDID since 5 Mar 2020 (UDI-DI 07613336121115), active as of 12 Nov 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K031824

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613336121115 UDI-DI Date5 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK031824 Date9 Jul 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031824 decided 9 Jul 2003 Active
  • FDA GUDID UDI-DI 07613336121115 listed 5 Mar 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-1921-2015 FDA Class II initiated 7 May 2015

    Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.

Timeline

3 dated events

  1. Cleared FDA 510(k) K031824
  2. Recall initiated FDA recalls Z-1921-2015
  3. Listed FDA GUDID 07613336121115

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cholesterol
Generic name
Total cholesterol lipid IVD, kit, spectrophotometry
Model / Ref / Catalog
08057443190
Primary DI / UDI-DI
07613336121115
510(k) Number
FDA product code
CHH
GMDN term
Total cholesterol lipid IVD, kit, spectrophotometry
Device class
Class I
Regulation number
862.1175
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total cholesterol lipid IVD, kit, spectrophotometry

Cleared under the same submission (K031824)

Similar devices in this category

Other devices filed under Total cholesterol lipid IVD, kit, spectrophotometry.

Other devices from Roche Diagnostics GmbH

See all devices from Roche Diagnostics GmbH →

Properties

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