Device classification

Automated Urinalysis System

Clinical Chemistry · 21 CFR 862.2900

Class IProduct code KQOExempt
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
KQO
Review panel
CH
Medical specialty
CH
Device name
Automated Urinalysis System
Medical specialty description
Clinical Chemistry
Device class
1
Regulation number
862.2900
Implant flag
N
Submission type ID
4
Harmonized identifiers (openFDA)
K number
K042421, K954514, K051526, K821738, K121456, K934042, K030600, K954158, K946183, K931602, K141874, K813056, K954156, K926359, K070929, K012829, K960054, K951877, K760472, K840996, K031947, K960546, K101852, K870526, K935408, K954024, K983510, K830220, K972141, K943463, K093098, K842238, K140717, K842237, K932674, K761306, K091472, K980047, K943592, K053253 +6 more
Registration number
1000369487, 3008517993, 1417592, 3015341499, 3004875840, 1036362, 3018771894, 3005360469, 3038206980, 3003795116, 3024082778, 3031915160, 3002637618, 3009448641, 2432235, 3006979678, 3043127699, 3013679502, 3034731501, 3006479639, 3027225088, 3006621318, 2122870, 3006198300, 3009495621, 3043088937, 3043138885, 3005146144, 3003741796, 4580, 3010324880, 9680746, 3008987086, 3015921024, 3027645317, 9610633, 1181121, 2531491, 1649661, 3007301207 +28 more
FEI number
1000369487, 3008517993, 1417592, 3015341499, 3004875840, 1036362, 3018771894, 3038206980, 3024082778, 3003795116, 3031915160, 2432235, 3002637618, 3009448641, 3006979678, 3043127699, 3013679502, 3034731501, 3006479639, 3027225088, 3006621318, 2122870, 3006198300, 3009495621, 3043088937, 3043138885, 1000306617, 1000206808, 3005146144, 3002806559, 3003741796, 4580, 3010324880, 3001451797, 3008987086, 3002806693, 3002829675, 3015921024, 3027645317, 3003516723 +28 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.