FDA product code SCH: Ldt, Approved By Nys Clep
SCH is the FDA product code for ldt, approved by nys clep. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under SCH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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).
Classification
| Field | Value |
|---|---|
| Device name | Ldt, Approved By Nys Clep |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for SCH devices
openFDA lists no recalls for product code SCH.
Frequently asked questions
What is FDA product code SCH?
SCH is the FDA product code for ldt, approved by nys clep. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is SCH?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SCH
- Run a recall and safety report across every SCH manufacturer
- Watch product code SCH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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