| Device |
infrared spectroscopy measurement, urinary calculi (stone) |
| Regulation Description |
Urinary calculi (stones) test system. |
| Regulation Medical Specialty |
Clinical Chemistry |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | JNP |
|---|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
862.1780
|
|---|
| Device Class |
1
|
| GMP Exempt? |
No
|
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. it is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| if a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the u.s. however, these manufacturers are required to register their establishment. please see the registration and listing website for additional information. |
| Third Party Review |
Not Third Party Eligible |
|
|
