FDA Product Code CIN: Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Leading manufacturers include Beckman Coulter.
26
Total
26
Cleared
95d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Electrophoretic Separation, Alkaline Phosphatase Isoenzymes Devices (Product Code CIN)
26 devices
About Product Code CIN - Regulatory Context
510(k) Submission Activity
26 total 510(k) submissions under product code CIN since 1976, with 26 receiving FDA clearance (average review time: 95 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
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