SCH — Ldt, Approved By Nys Clep Class N
FDA product code SCH covers "Ldt, Approved By Nys Clep", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SCH
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- No
Definition
Laboratory developed tests (LDTs) that are approved by the New York State Department of Health Clinical Laboratory Evaluation Program (NYS CLEP) described in section V.B.2 of the preamble to the LDT Final Rule (89 FR 37286).