FDA Product Code JMT: Diazo (colorimetric), Nitrite (urinary, Non-quant)
Leading manufacturers include Safecare Biotech (Hangzhou) Co., Ltd., Healgen Scientific, LLC and Hangzhou AllTest Biotech Co., Ltd..
FDA 510(k) Cleared Diazo (colorimetric), Nitrite (urinary, Non-quant) Devices (Product Code JMT)
About Product Code JMT - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code JMT since 1984, with 13 receiving FDA clearance (average review time: 175 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under JMT have taken an average of 129 days to reach a decision - down from 189 days historically, suggesting improved FDA processing for this classification.
JMT devices are reviewed by the Chemistry panel. Browse all Chemistry devices →