510(k) K013359
K013359 is an FDA 510(k) premarket notification submitted by Denka Seiken'S for the device "LP(A)-LATEX SEIKEN ASSAY KIT". The FDA issued a decision of Substantially Equivalent on March 8, 2002. The device falls under product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5600. Denka Seiken'S has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2002
- Date Received
- October 10, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5600
- Review Panel
- IM
- Submission Type