Device classification

Electrophoretic Separation, Lipoproteins

Clinical Chemistry · 21 CFR 862.1475

Class IProduct code JHOExempt
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
JHO
Review panel
CH
Medical specialty
CH
Device name
Electrophoretic Separation, Lipoproteins
Medical specialty description
Clinical Chemistry
Device class
1
Regulation number
862.1475
Implant flag
N
Submission type ID
4
Harmonized identifiers (openFDA)
K number
K960785, K000603, K781970, K013466, K854057, K010337, K871319, K802822, K971157, K974854, K013662, K780256, K012789, K022053, K960571, K935162, K962914, K791606, K980650, K833611, K893223, K992971, K940679, K964471, K881809, K022333
Registration number
1318354, 2020715, 8023024, 1618982
FEI number
6387, 1318354, 2020715, 1618982
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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.