Atlas FDA

CDN

16 FDA 510(k) clearances · Product code

55 daysmedian time to decision
268 days90th percentile
16clearances measured

FDA profile

Official device name
Urease, Photometric, 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
VITROS XT Chemistry Products UREA-CREA Slides (K190326)Ortho-Clinical Diagnostics, Inc.2019-03-14
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE (K132462)Hitachi Chemical Diagnostics, Inc.2013-10-28
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT (K123322)Alfa Wassermann Diagnostics Technologies, LLC2013-05-21
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT (K113389)Alfa Wassermann Diagnostic Technologies, Inc.2012-08-10
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD (K103615)Alfa Wassermann Diagnostic Technologies, Inc.2011-09-08
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K001885)Ortho-Clinical Diagnostics, Inc.2000-07-20
CHOLESTECH BUN/CREATININE TEST SYSTEM (K972012)Cholestech Corp.1997-07-24
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) (K961196)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-15
BUN QVET (K943042)Prisma Systems1994-12-29
KING DIAGNOSTICS UREA NITROGEN REAGENT (K922969)King Diagnostics, Inc.1992-10-13
QUICKSTART UREA NITROGEN (K914903)Em Diagnostic Systems, Inc.1991-12-31
UREA NITROGEN (ENZYMATIC) DETERMINATION (K822154)The Dow Chemical Co.1982-08-05
BUN REAGENT ASTRA 4 & 8 ANALYZERS (K802518)Nobel Scientific Industries, Inc.1980-11-12
STATTEK BUN (K792328)Boehringer Mannheim Corp.1979-12-18
BUN (UREASE) REAGENT (K781253)Coulter Electronics, Inc.1978-08-21
MULTISTAT III UREA NITROGEN TEST (K771442)Instrumentation Laboratory CO1977-08-22

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