510(k) K042322

Device: STERICHEK BLOOD LEAK REAGENT STRIPS
Applicant: HACH COMPANY
510(k) number: K042322
Product code: FJD
Decision: Substantially Equivalent (SESE)
Decision date: 2004-12-07
Date received: 2004-08-26
Regulation: 876.5820
Classification name: Detector, Leak, Blood
Medical specialty: Gastroenterology/Urology
Review panel: Gastroenterology/Urology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: DAVID A MORRIS, PH.D.
Address: 23575 County Rd. 106 Elkhart IN US 46514 46514

FDA Registration Numbers#

1833387
2028411

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00851575007129	SteriChek® Blood Leak Reagent Strips	HACH COMPANY	2016-10-28
00851575007105	SteriChek® Blood Leak Reagent Strips	HACH COMPANY	2016-10-28

Other 510(k) Records For Product Code FJD #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K123805	E-Z CHEK BLOOD LEAK TEST STRIPS	Reprocessing Products Corp	2013-03-20
K012115	SERIM BLOOD LEAK TEST STRIP-2	Serim Research Corp.	2001-11-30
K990206	SERIM BLOOD LEAK TEST STRIP	Serim Research Corp.	1999-04-21

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases