Device classification

System, Automated Platelet Aggregation

Hematology · 21 CFR 864.5700

Class IIProduct code JOZ
Open FDA's page for this record
Third party flag
Y
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
JOZ
Review panel
HE
Medical specialty
HE
Device name
System, Automated Platelet Aggregation
Medical specialty description
Hematology
Device class
2
Regulation number
864.5700
Implant flag
N
Submission type ID
1
Harmonized identifiers (openFDA)
K number
K770395, K970505, K781807, K781693, K032951, K181777, K791577, K962426, K050265, K023761, K954997, K760893, K051231, K163274, K013596, K992531, K790769, K103555, K161329, K940792, K122162, K800432, K862302, K990398, K140893, K012701, K780285, K011337, K191364, K012723, K800146, K060489, K002885, K851669, K042423, K780047, K141427, K041502
Registration number
1000487132, 1217183, 2518152, 3019849102, 9610806, 8020030, 1219343, 3005269352, 3002807408, 3016571810, 3002721930, 3016579901, 1618982, 3003455467, 3003601075, 3017875469, 3005739529
FEI number
1000487132, 1217183, 2250033, 3019849102, 2518152, 1219343, 3001644026, 3005269352, 3002807408, 3016571810, 1618982, 3016579901, 3006461677, 3003455467, 3003601075, 3017875469, 3005739529
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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.