510(k) K041090
K041090 is an FDA 510(k) premarket notification submitted by Denka Seiken Co., Ltd. for the device "HDL-EX SEIKEN ASSAY KIT". The FDA issued a decision of Substantially Equivalent on October 29, 2004. The device falls under product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl), 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
- October 29, 2004
- Date Received
- April 26, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type