Atlas FDA

CDL

16 FDA 510(k) clearances · Product code

37 daysmedian time to decision
72 days90th percentile
16clearances measured

FDA profile

Official device name
Berthelot Indophenol, 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
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT (K896845)Reagents Applications, Inc.1990-02-16
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 (K893128)Stanbio Laboratory1989-07-25
COLORIMETRIC BUN REAGENT KIT (K871651)Biochemical Trade, Inc.1987-05-12
UREA NITROGEN(BUN), COLORIMETRIC METHOD (K864742)Tech-Co, Inc.1987-01-13
UREA NITROGEN TEST (K863889)U. S. Diagnostics, Inc.1986-11-24
UREAFAST (K863076)J. D. Assoc.1986-09-09
BUN (ENZYMATIC BERTHELOT) REAGENT SET (K860154)Sterling Diagnostics, Inc.1986-02-06
COLORIMETRIC BUN (K831414)Bio-Analytics Laboratories, Inc.1983-06-16
UREA NITROGEN REAGENT SET (MOD. BERTHEL (K822237)Sterling Biochemical, Inc.1982-08-16
EUROCHIMA UREA NITROGEN (K810261)Volu Sol Medical Industries1981-02-10
DATA-ZYME UREA NITROGEN, COLORIMETRIC (K801727)Data Medical Associates, Inc.1980-09-09
BUN-COLOR 2, BLOOD UREA NITROGEN TEST (K800902)Sclavo, Inc.1980-06-09
ELVI BLOOD UREA NITROGEN (K792417)Volu Sol Medical Industries1979-12-07
UREA NITROGEN TEST (K781899)Wako Intl., Inc.1978-12-20
UREA NITROGEN TEST KIT (K781306)Analytical & Research Chemicals, Inc.1978-08-31
S-UREA-N, IN VITRO DIAG FOR BUN (K761152)Advanced Biomedical Methods, Inc.1976-12-09

Track CDL automatically

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