Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3002619777.
Observations4
Issue DateFebruary 09, 2026
StatusNo Warning Letter
Establishment TypeManufacturer
Related Inspections5
Establishment Details
Firm
Collaborative Care Diagnostics, LLC.
Location
Eagan, Minnesota
FEI Number
3002619777
Establishment Type
Manufacturer
Product Type
Devices
Issue Date
February 09, 2026
Country
United States
Inspection History, 2009 to 2026
NAI3
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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