FDA Product Code KTL: Anti-dna Indirect Immunofluorescent Solid Phase
19
Total
19
Cleared
160d
Avg days
1979
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Anti-dna Indirect Immunofluorescent Solid Phase Devices (Product Code KTL)
19 devices
No devices found for this product code.
About Product Code KTL - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code KTL since 1979, with 19 receiving FDA clearance (average review time: 160 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.