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Serim Research Corp.

FDA Regulatory Profile

Serim Research Corp. has 0 FDA recalls, 4 inspections, 31 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 30, 2025 · VAI
Latest 510(k)
Mar 17, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances31Oct 4, 2026Not statedCurrent
Inspections4Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 30, 2025Elkhart, INDevicesVoluntary Action Indicated (VAI)1833387
Apr 7, 2022Elkhart, INDevicesNo Action Indicated (NAI)1833387
Feb 23, 2018Elkhart, INDevicesNo Action Indicated (NAI)1833387
Sep 26, 2014Elkhart, INDevicesVoluntary Action Indicated (VAI)1833387

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K253863GUARDIAN™ Quick Dip Residual Chlorine (5212)Mar 17, 2026
K251035DISINTEK™ PA Test StripsJun 3, 2025
K202565WAVICIDE-OPA MEC IndicatorDec 2, 2020
K192445QwikCheck Chemical IndicatorsApr 2, 2020
K120652RAPICIDE OPA-28 TEST STRIPOct 12, 2012
K092346SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171Jan 7, 2010
K083295SERIM DISINTEK GTA 2.1%, MODEL: 5164Mar 16, 2009
K082352SERIM DISINTEK OPA TEST STRIPSep 25, 2008
K081370SERIM DISINTEK OPA TEST STRIPJul 11, 2008
K080712SERIM HISENSE ULTRA 0.1, PART NUMBER 5167May 6, 2008
K052388SERIM PERACETIC ACID CHEMICAL INDICATORDec 1, 2005
K043031SERIM DIALYSATE MONITOR TEST STRIPJun 13, 2005
K014038PYLORITEK VP TEST KIT 5140VPFeb 8, 2002
K012115SERIM BLOOD LEAK TEST STRIP-2Nov 30, 2001
K000578SERIM LEUKOCYTE ESTERASE TEST STRIPSMay 5, 2000
K992341CIDEX OPA SOLUTION TEST STRIPNov 23, 1999
K990206SERIM BLOOD LEAK TEST STRIPApr 21, 1999
K972035SPOROX TEST STRIPSAug 29, 1997
K953632SERIM PYLORITEK TEST KITDec 18, 1995
K952215SERIM HISENSE TEST KITAug 9, 1995

FDA data resources