510(k) K043264
K043264 is an FDA 510(k) premarket notification submitted by Denka Seiken Co., Ltd. for the device "LDL-EX SEIKEN ASSAY KIT". The FDA issued a decision of Substantially Equivalent on January 26, 2005. The device falls under product code MRR (System, Test, Low Density, Lipoprotein), a Class I device regulated under 21 CFR 862.1475. Denka Seiken Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 2005
- Date Received
- November 24, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Low Density, Lipoprotein
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type