510(k) K060677
K060677 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "N LATEX CDT". The FDA issued a decision of Substantially Equivalent on August 25, 2006. The device falls under product code NAO (Test, Carbohydrate Deficient Transferrin), a Class I device regulated under 21 CFR 862.1360. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2006
- Date Received
- March 14, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Carbohydrate Deficient Transferrin
- Device Class
- Class I
- Regulation Number
- 862.1360
- Review Panel
- CH
- Submission Type