Atlas FDA

MNV

6 FDA 510(k) clearances · Product code

348 daysmedian time to decision
571 days90th percentile
6clearances measured

FDA profile

Official device name
Strip, Dialysate Ph Indicator
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
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RecordFirmDate
RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH TEST STRIPS, MODEL K100-0104 (K101750)Reprocessing Products Corp2011-01-07
STERICHEK BICARB PH REAGENT STRIPS (K031267)Environmental Test Systems, Inc.2003-12-23
MITEK MINI ANCHOR (K936311)Mitek Surgical Products, Inc.1995-10-31
MITEK ABSORBABLE ANCHOR (K941599)Mitek Surgical Products, Inc.1995-10-24
ABSORBALBE ANCHOR (K944051)Mitek Surgical Products, Inc.1995-08-02
SERIM(TM) BICARB PH REAGENT STRIPS (K945491)Serim Research Corp.1995-02-01

Track MNV automatically

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