HACH COMPANY

FDA Device Registration & Listing · AMES, IA, US · Registration 1833407

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1833407
FEI Number
1000518597
Entity Name
HACH COMPANY
City/State/Country
AMES, IA, US
Establishment Address
100 DAYTON AVE., AMES, IA 50010, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
HACH COMPANY (Owner Number: 9001544)
Owner / Operator Contact Address
100 Dayton Avenue, --, Ames, IA 50010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Hach CM130 Chlorine Monitor VITEK 2 DENSICHEK PLUS Reference Standards

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2017-05-08
PSX Chlorine Meter Gastroenterology, Urology Class 2 876.5665 2017-05-08
LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation Microbiology Class 2 866.1645 2013-04-02

Official Correspondent

Megan Wenndt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HACH COMPANY
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20
K033458 Becton, Dickinson & CO BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST 2004-05-28
K112000 bioMerieux, Inc. VITEK 2 STREPTOCOCCUS PENICILLIN 2011-10-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-05 Ameriwater Inc 2
AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.
Z-0170-2015 Siemens Healthcare Diagnostics, Inc. 2
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

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3003550196 Veolia Water Treatment & Solutions ARLINGTON, TX, US
9611824 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH SCHWEINFURT Bavaria, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1833407. Last updated year: 2026. Please use registration number 1833407 when referencing this establishment in official correspondence.
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