510(k) K123805

Device: E-Z CHEK BLOOD LEAK TEST STRIPS
Applicant: REPROCESSING PRODUCTS CORP.
510(k) number: K123805
Product code: FJD
Decision: Substantially Equivalent (SESE)
Decision date: 2013-03-20
Date received: 2012-12-11
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: TED WILLIAMS
Address: P.O. Box 35849 Tucson AZ US 85740 85740

FDA Registration Numbers#

1833387
2028411

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00858293006397	EZ-Chek	REPROCESSING PRODUCTS CORPORATION	2017-03-07
00858293006175	EZ-Chek	REPROCESSING PRODUCTS CORPORATION	2017-03-07

Other 510(k) Records For Product Code FJD #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K042322	STERICHEK BLOOD LEAK REAGENT STRIPS	Hach Company	2004-12-07
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#

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