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Ace SA1050

by Alfa Wassermann, Inc.

Ace SA1050 is a Class II device made by Alfa Wassermann, Inc., cleared under FDA 510(k) K170623 on 27 Feb 2018 and listed in FDA GUDID since 3 Apr 2020 (UDI-DI 00857969006617), 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) K170623

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 Number00857969006617 UDI-DI Date3 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170623 Date27 Feb 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170623 decided 27 Feb 2018 Active
  • FDA GUDID UDI-DI 00857969006617 listed 3 Apr 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170623
  2. Listed FDA GUDID 00857969006617

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ace
Generic name
Glycated haemoglobin (HbA1c) IVD, reagent
Model / Ref / Catalog
SA1050
Primary DI / UDI-DI
00857969006617
510(k) Number
FDA product code
LCP
GMDN term
Glycated haemoglobin (HbA1c) IVD, reagent
Device class
Class II
Regulation number
864.7470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, reagent

Similar devices in this category

Other devices filed under Glycated haemoglobin (HbA1c) IVD, reagent.

Other devices from Alfa Wassermann, Inc.

See all devices from Alfa Wassermann, Inc. →

Properties

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