Product code SCH

Device name

Ldt, Approved By Nys Clep

Medical specialty

Unknown

Device class

N

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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).

Source

FDA openFDA device classification dataset