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Serim Research

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251035DISINTEK™ PA Test StripsJune 3, 2025
K120652RAPICIDE OPA-28 TEST STRIPOctober 12, 2012
K092346SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171January 7, 2010
K083295SERIM DISINTEK GTA 2.1%, MODEL: 5164March 16, 2009
K082352SERIM DISINTEK OPA TEST STRIPSeptember 25, 2008
K081370SERIM DISINTEK OPA TEST STRIPJuly 11, 2008
K080712SERIM HISENSE ULTRA 0.1, PART NUMBER 5167May 6, 2008
K052388SERIM PERACETIC ACID CHEMICAL INDICATORDecember 1, 2005
K043031SERIM DIALYSATE MONITOR TEST STRIPJune 13, 2005
K014038PYLORITEK VP TEST KIT 5140VPFebruary 8, 2002
K012115SERIM BLOOD LEAK TEST STRIP-2November 30, 2001
K000578SERIM LEUKOCYTE ESTERASE TEST STRIPSMay 5, 2000
K992341CIDEX OPA SOLUTION TEST STRIPNovember 23, 1999
K990206SERIM BLOOD LEAK TEST STRIPApril 21, 1999
K972035SPOROX TEST STRIPSAugust 29, 1997
K953632SERIM PYLORITEK TEST KITDecember 18, 1995
K952215SERIM HISENSE TEST KITAugust 9, 1995
K945491SERIM(TM) BICARB PH REAGENT STRIPSFebruary 1, 1995
K932047WAVICIDE MONITOR STRIPSJune 2, 1994
K936034SERIM PYLORITEK REAGENT STRIPSApril 21, 1994