LLH · Class I · 21 CFR 866.2660

FDA Product Code LLH: Reagents, Clostridium Difficile Toxin

42
Total
42
Cleared
130d
Avg days
1985
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Reagents, Clostridium Difficile Toxin Devices (Product Code LLH)

42 devices
1–24 of 42
No devices found for this product code.

About Product Code LLH - Regulatory Context

510(k) Submission Activity

42 total 510(k) submissions under product code LLH since 1985, with 42 receiving FDA clearance (average review time: 130 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.