510(k) K990206

Device: SERIM BLOOD LEAK TEST STRIP
Applicant: SERIM RESEARCH CORP.
510(k) number: K990206
Product code: FJD
Decision: Substantially Equivalent (SESE)
Decision date: 1999-04-21
Date received: 1999-01-21
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: ROBERT J CARRICO
Address: 23565 Reedy Dr. Elkhart IN US 46514 46514

FDA Registration Numbers#

1833387
2028411

Source Documents#

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
K042322	STERICHEK BLOOD LEAK REAGENT STRIPS	Hach Company	2004-12-07
K012115	SERIM BLOOD LEAK TEST STRIP-2	Serim Research Corp.	2001-11-30

Legacy Summary#

summary

FDA Review#

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