Atlas FDA

MSY

13 FDA 510(k) clearances · Product code

98 daysmedian time to decision
349 days90th percentile
13clearances measured

FDA profile

Official device name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5665
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
2008: 35
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Chlorine Sentinel II (K243898)Nelson Environmental Technologies, Inc.2025-04-11
E-Z Chek Chlorine Residual Test Strips (K100-0101B) (K222167)Reprocessing Products Corporation (Rpc)2022-10-18
Nelson Sentinel Series Basic Chlorine Sentinel (K193169)Nelson Environmental Technologies, Inc.2020-10-29
E-Z CHECK OZONE TEST STRIPS (K132344)Reprocessing Products Corporation (Rpc)2014-02-25
ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE (K090338)Reprocessing Products Corp2009-05-08
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 (K080712)Serim Research Corp.2008-05-06
GLUTARTEST 1 REAGENT STRIP (K002011)Integrated Biomedical Technology, Inc.2001-01-22
STERICHEK TOTAL CHLORINE REAGENT STRIPS (K001194)Environmental Test Systems, Inc.2000-07-11
STERICHEK TOTAL CHLORINE REAGENT STRIPS (K994226)Environmental Test Systems, Inc.2000-03-22
STERICHEK TOTAL CHLORINE TEST KIT (K983997)Environmental Test Systems, Inc.1999-04-02
MICRO X RESIDUAL TEST STRIPS (K974064)Reprocessing Products Corp1998-12-07
STERICHEK PERACETIC ACID REAGENT STRIPS (K980164)Environmental Test Systems, Inc.1998-04-16
STERICHEK CHLORINE REAGENT STRIPS (K971598)Environmental Test Systems, Inc.1997-07-18

Track MSY automatically

Every clearance here is in the API, with alerts when new ones post.