Atlas FDA

FLB

6 FDA 510(k) clearances · Product code

87 daysmedian time to decision
475 days90th percentile
6clearances measured

FDA profile

Official device name
Meter, Conductivity, Induction, Remote Type
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
DIALYSATE METER, MODEL D-6 (K100237)Myron L Company2010-04-23
90DX MULTITEST METER, MODIFICATION (K925210)Mesa Medical, Inc.1994-01-25
MODEL 90DX MULTITEST METER (K882032)Mesa Medical, Inc.1988-08-11
COBE RX METER (K830629)Cobe Laboratories, Inc.1983-04-06
MODEL 90 BC (K821415)Western Laboratories Corp.1982-05-27
DIALYSATE METER RS-2100A, CIRCUIT CHANGE (K770263)Renal Systems, Inc.1977-02-18

Track FLB automatically

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