SERIM BLOOD LEAK TEST STRIP

Detector, Leak, Blood

SERIM RESEARCH CORP.

The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Blood Leak Test Strip.

Pre-market Notification Details

Device IDK990206
510k NumberK990206
Device Name:SERIM BLOOD LEAK TEST STRIP
ClassificationDetector, Leak, Blood
Applicant SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart,  IN  46514
ContactRobert J Carrico
CorrespondentRobert J Carrico
SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart,  IN  46514
Product CodeFJD  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-21
Decision Date1999-04-21
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.