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Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

FDA product code NVI · 1 cleared devices

Class 2 Clinical Toxicology
Regulation
21 CFR 862.3100
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2005-10-27 – 2005-10-27

The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests.

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