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Serim Blood Leak Test Strip

FDA 510(k)

Class II (US FDA 510(k))

510(k) K990206

by Serim Research Corp.

Identifiers

510(k) Number
K990206 FDA 510(k)
FDA Product Code
FJD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5820 FDA 510(k)
Regulation Number
876.5820 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Serim Blood Leak Test Strip is a detector for blood leaks, classified as a Class II medical device under regulation number 876.5820. It is designed to detect the presence of blood in fluids, providing a rapid and accurate method to determine if a blood leak alarm is due to an actual blood leak.

Supplied as a test strip in a bottle containing 50 strips, the device is intended for use in medical facilities to verify blood leak alarms. It is a single-use in vitro diagnostic tool, with no claims of sterility, MRI safety, or reusability stated in the data. The device received FDA 510(k) clearance (K990206) on April 21, 1999, and is classified under the product code FJD, with medical specialty descriptions in Gastroenterology and Urology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Serim - The Test Strip Specialists, GUARDIAN™ Blood Leak Test Strips - Blood Leak | Serim, Serim Research Corp BLOOD LEAK TEST-50 STRIPS/BTL, Serim Blood Leak Test Strips | Nipro Canada

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Serim Research Corp.

Sources (1)

  • FDA 510(k) K990206 24 fields · synced Sep 24, 2026