Atlas FDA

CDF

12 FDA 510(k) clearances · Product code

48 daysmedian time to decision
120 days90th percentile
12clearances measured

FDA profile

Official device name
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
Device class
Class I (low risk)
Regulation
21 CFR 862.1795
Medical specialty
Clinical Chemistry
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RecordFirmDate
PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM (K953077)Beckman Instruments, Inc.1996-01-05
MODEL 5500 CEAS (K934977)Esa, Inc.1994-01-11
HVA EIA KIT YAMASA (K895288)Yamasa Shoy Co., Ltd.1989-10-31
VMA EIA KIT YAMASA (K895287)Yamasa Shoy Co., Ltd.1989-10-30
HVA & HOMOVANILLIC ACID BY HPLC METHOD (K873372)Bio-Rad1987-12-22
VANILMANDELIC ACID (VMA) REAGENT SET (K861962)Sterling Diagnostics, Inc.1986-07-07
VMA BY HPLC TEST (VANILMANDELIC ACID) (K861010)Bio-Rad1986-05-01
TRIGLYCERIDES LCK 124 (K853041)German American Chamber of Commerce, Inc.1985-08-12
VMA ASSAY KIT (K843379)Diagnostic Chemicals, Ltd. (Usa)1984-09-28
HELENA VMA-SMC COLUMN METHOD (K810992)Helena Laboratories1981-04-29
VMA BY COLUMN TEST (K791837)Bio-Rad1979-10-30
URINARY VMA - SCREEN TEST KIT (K772151)Eppendorf-Brinkmann, Inc.1977-11-30

Track CDF automatically

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