Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1825740

FEI Number

1825740

Entity Name

Analytical Control Systems

City/State/Country

Fishers, IN, US

Establishment Address

9058 Technology Drive, Fishers, IN 46038, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ANALYTICAL CONTROL SYSTEMS (Owner Number: 1825740)

Owner / Operator Contact Address

9058 TECHNOLOGY DR., --, Fishers, IN 46038, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K930477

PMA Number

N/A

All Registered Proprietary Names

Angiotensin Converting Enzyme Calibrator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-12-24

Official Correspondent

Eric BONDERMAN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ANALYTICAL CONTROL SYSTEMS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022	Sentinel CH SpA Via Robert Koch	2	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

Similar Registrations

Registration Number	Establishment Name	Location
3000148879	HORIBA ABX SAS	MONTPELLIER Herault, FR
3003522182	FUJIFILM Healthcare Manufacturing Corporation MIE Office	Komono-cho, Mie-gun, JP
1181121	Fisher Diagnostics	MIDDLETOWN, VA, US
2250051	ORTHO-CLINICAL DIAGNOSTICS, INC.	RARITAN, NJ, US
9612316	TOSOH AIA, INC.	TOYAMA, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1825740. Last updated year: 2026. Please use registration number 1825740 when referencing this establishment in official correspondence.