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ACE Control Set 1667001

by Sentinel Ch. Srl

ACE Control Set 1667001 is a Class I device made by Sentinel Ch. Srl, cleared under FDA 510(k) K940272 on 20 Apr 1994 and listed in FDA GUDID since 29 Jul 2016 (UDI-DI 08058056681775), 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) K940272

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 Number08058056681775 UDI-DI Date29 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK940272 Date20 Apr 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K940272 decided 20 Apr 1994 Active
  • FDA GUDID UDI-DI 08058056681775 listed 29 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K940272
  2. Listed FDA GUDID 08058056681775

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ACE Control Set
Generic name
Angiotensin converting enzyme (ACE) IVD, control
Model / Ref / Catalog
1667001
Primary DI / UDI-DI
08058056681775
510(k) Number
FDA product code
JJX
GMDN term
Angiotensin converting enzyme (ACE) IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 6 Milliliter

Related devices

Category: Angiotensin converting enzyme (ACE) IVD, control

Cleared under the same submission (K940272)

Similar devices

Other devices filed under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)).

Other devices from Sentinel Ch. Srl

See all devices from Sentinel Ch. Srl →

Properties

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