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NTY

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
Device class
Class II (moderate risk)
Regulation
21 CFR 866.6010
Medical specialty
Immunology
Flags
Third-party review eligible
FDA definition
MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.
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RecordFirmDate
AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 (K072901)Amdl, Inc.2008-07-01

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Every clearance here is in the API, with alerts when new ones post.