510(k) K072901
K072901 is an FDA 510(k) premarket notification submitted by Amdl, Inc. for the device "AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101". The FDA issued a decision of Substantially Equivalent on July 1, 2008. The device falls under product code NTY (System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer), a Class II device regulated under 21 CFR 866.6010. Amdl, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2008
- Date Received
- October 11, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type
MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.