510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SCFNot classified

Ldt, Unmet Need Within An Integrated Healthcare System

Unknown
FDA source (opens on fda.gov)

SCF is the FDA product code for Ldt, Unmet Need Within An Integrated Healthcare System. FDA's definition for this code reads: "Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286)". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SCF
Device name
Ldt, Unmet Need Within An Integrated Healthcare System
FDA definition
Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SCF.