SCG · Modified Version Of Another ManufacturerS Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule
· Class N
Overview
| Product Code | SCG |
|---|---|
| Device Name | Modified Version Of Another ManufacturerS Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule |
| Device Class | Class N |
| Review Panel |
Identification
When a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meeting CLIAs regulatory requirements to perform high complexity testing modifies another manufacturers 510(k) cleared or De Novo authorized test, and in compliance as described in section V.C.3 of the preamble to the LDT Final Rule, in a manner that could not significantly affect the safety or effectiveness of the test and does not constitute a major change or modification in intended use, and where the modified test is performed only in the laboratory making the modification as described in sections V.C.4 and V.C.5 of the preamble to the LDT Final Rule (89 FR 37286).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
