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Hach Company: FDA-registered device maker in Ames, IA, United States, 1 510(k) clearance

Name: Hach Company FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hach Company is registered with the FDA (registration 1833407) in Ames, IA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 30, 2017. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1833407
FEI number: 1000518597
Address: 100 Dayton Ave., Ames, IA, United States, 50010
Owner or operator: HACH COMPANY (9001544)
Roles: Contract manufacturer, Manufacturer
First device listed: April 2, 2013
Registered through: 2027
Brand names listed: Hach CM130 Chlorine Monitor, VITEK 2 DENSICHEK PLUS Reference Standards

Devices it lists

Device	Product code	Class	Role	Source
Chlorine Meter	PSX	2	Manufacturer	accessdata.fda.gov
Subsystem, Water Purification	FIP	2	Manufacturer	accessdata.fda.gov
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	LON	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 30, 2017	K162471	Hach CM130 Chlorine Monitoring System	PSX	Substantially Equivalent	Hach Company	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 21, 2009	51966	Not yet classified	Terminated	HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part #811905, Bottle part #1905LB, Hach Co., Ames, IA. SteriChek Residual Peroxide Reagent Strips provide a convenient means of measuring	Some of the reagent strip bottles contain the incorrect strips	accessdata.fda.gov
May 23, 2008	48613	Not yet classified	Terminated	HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bottles containing 100 strips each, 5 bottles per kit, Part #81190	Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results	accessdata.fda.gov

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Updated March 30, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.