Atlas FDA

CDS

15 FDA 510(k) clearances · Product code

68 daysmedian time to decision
257 days90th percentile
15clearances measured

FDA profile

Official device name
Electrode, Ion Specific, Urea Nitrogen
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1770
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
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RecordFirmDate
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test (K171247)Epocal, Inc.2018-01-17
BUN REAGENT (K040973)Genchem, Inc.2004-12-27
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT (K033056)Diamond Diagnostics, Inc.2004-01-30
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 (K925550)Hichem Diagnostics1993-04-20
BLOOD UREA NITROGEN (BUN) TESTCARD (K860543)Ilex Corp.1986-04-21
CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS (K855091)Sen Tech Medical Corp.1986-03-14
LANCER BUN RATE REAGENT KIT (K812308)Sherwood Medical Co.1981-08-31
BUN RATE REAGENT (K811193)Chem-Elec, Inc.1981-07-10
BUN REAGENT KIT #88108 (K800616)Hi Chem, Inc.1980-04-10
BUN KIT (K800590)Nobel Scientific Industries, Inc.1980-04-04
BUN REAGENT KIT (K800071)Fisher Scientific Co., LLC1980-02-05
FERMCOTEST R BUN RATE REAGENT TEST KIT (K791018)Fermco Biochemics, Inc.1979-07-17
DIAG. CONDUCTA RATE BUN REAG. SET (K771060)J.T. Baker Chemical Co.1977-07-21
BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 (K761061)Beckman Instruments, Inc.1977-01-25
BUN-REATIVE (K760430)Boehringer Mannheim Corp.1976-11-01

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