510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MSYClass II

Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

21 CFR 876.5665 / Gastroenterology, Urology
FDA source (opens on fda.gov)

MSY is the FDA product code for Strip, Test, Reagent, Residuals For Dialysate, Disinfectant, a class II device type, regulated under 21 CFR 876.5665. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MSY
Device name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
0

Clearances, product code MSY

By decision year
13 clearances under product code MSY with a decision year between 1997 and 2025, 1998 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MSY by decision year
YearClearances
19971
19982
19991
20002
20011
20081
20091
20141
20201
20221
20251

Applicants with the most clearances

Product code MSY
Applicants holding the most 510(k) clearances under product code MSY
ApplicantClearances
Environmental Test Systems, Inc.5
Nelson Environmental Technologies, Inc.2
Reprocessing Products Corp2
Reprocessing Products Corporation (RPC)2
Integrated Biomedical Technology, Inc.1
Serim Research Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code