# K990206: Serim Blood Leak Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Apr 21, 1999 after 90 days
- Product code: FJD (Detector, Leak, Blood)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896454 (1990). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896454: Chemstrip (R) 10 with SG Urine Test Strips, Boehringer Mannheim Corp. (1990) Summary page 1.

## Most influential descendants
- K012115: Serim Blood Leak Test Strip-2 (2001), 1 descendant of its own
- K042322: Sterichek Blood Leak Reagent Strips (2004), 0 descendants of its own

## Indications for use
SERIM Blood Leak Test Strips provide a rapid and convenient means for testing spent dialysate for blood in hemodialysis clinics. The presence of blood in dialysate indicates a leak in the dialysis membrane.

Source page: https://510kreport.com/device/K990206
Methodology: https://510kreport.com/methodology