Ldt, Approved By Nys Clep

SCH · Not classified · Unknown

Classification

FDA Product Code: SCH
Device class: Not classified
Regulation: —
Review panel: CH
Medical specialty: Unknown
Submission type: 7
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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).

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown