Atlas FDA

CDW

21 FDA 510(k) clearances · Product code

35 daysmedian time to decision
84 days90th percentile
21clearances measured

FDA profile

Official device name
Diacetyl-Monoxime, 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
BLOOD UREA NITROGEN (K874532)Catachem, Inc.1988-01-05
FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 (K871320)American Research Products Co.1987-04-22
AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 (K863425)American Research Products Co.1986-10-01
TWIN BUN/GLUCOSE (K861775)Boehringer Mannheim Corp.1986-06-27
UREA NITROGEN REAGENT SET (K860419)Sterling Diagnostics, Inc.1986-02-11
UREA (K850937)Dilab, Inc.1985-06-10
UREA NITROGEN REAGENT SET (K844156)Livonia Diagnostics, Inc.1984-11-13
UREA NITROGEN REAGENT SET (K841068)Medical Specialties, Inc.1984-05-01
ULTRACHEM BUN-UV, 65080 & 65081 (K822323)Harleco Diagnostics1982-09-02
UREA NITROGEN REAGENT SET (K821212)Omega Medical Electronics1982-07-22
UREA NITROGEN REAGENT SET (K813415)Anco Medical Reagents & Assoc.1981-12-31
BUN COLOR REAGENT & BUN ACID USED (K802160)Panmed, Inc.1980-10-10
SMAC REPLACEMENT REAGENTS/OF BUN-SERUM (K800673)Diagnostic Solutions, Inc.1980-05-28
SERUM, BLOOD UREA NITIOGEN (K781885)Fisher Scientific Co., LLC1978-12-20
UREA NITROGEN (K781305)Analytical & Research Chemicals, Inc.1978-08-31
DIRECT UREA NITROGEN TEST (K780262)Hycel, Inc.1978-04-05
BLOOD UREA NITROGEN BUN (K771830)Gamma Enterprises, Inc.1977-10-25
BLOOD UREA NITROGEN (BUN) REAGENT (K771312)Mallinckrodt Critical Care1977-08-03
UNIPAK BUN (K771087)Harleco1977-07-21
WORTHINGTON BUN (K770470)Worthington Biochemical Corp.1977-06-02
REAGENT, BUN (UREA NITROGEN) DETERM. (K760478)Simmler & Son, Inc.1976-10-29

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