← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

SCH — Ldt, Approved By Nys Clep

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).

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CH
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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