Ace SA1045

by Alfa Wassermann, Inc.

Ace SA1045 is a Class I device made by Alfa Wassermann, Inc., cleared under FDA 510(k) K113438 on 1 Jun 2012 and listed in FDA GUDID since 10 Oct 2017 (UDI-DI 00857969006549), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00857969006549 UDI-DI	Date10 Oct 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK113438	Date1 Jun 2012Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00857969006549
FDA 510(k) database 510(k) number K113438

Across registries

2 registries list this device

FDA 510(k) K113438 decided 1 Jun 2012 Active
FDA GUDID UDI-DI 00857969006549 listed 10 Oct 2017 Listed

Timeline

2 dated events

1 Jun 2012 Cleared FDA 510(k) K113438
10 Oct 2017 Listed FDA GUDID 00857969006549

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Ace
Generic name: Lipase IVD, reagent
Model / Ref / Catalog: SA1045

Primary DI / UDI-DI: 00857969006549
510(k) Number: K113438
FDA product code: CHI
GMDN term: Lipase IVD, reagent

Device class: Class I
Regulation number: 862.1465
GUDID distribution status: In Commercial Distribution

Similar devices

Other devices filed under FDA product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase).

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Properties

Convenience kit
Lot / batch number
Expiration date

Other properties (12, all answered No)