510(k) K161679
K161679 is an FDA 510(k) premarket notification submitted by Denka Seiken Co., Ltd. for the device "s LDL-EX SEIKEN". The FDA issued a decision of Substantially Equivalent on August 18, 2017. The device falls under product code PYP (Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test), 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
- August 18, 2017
- Date Received
- June 17, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
- Device Class
- Class I
- Regulation Number
- 862.1475
- Review Panel
- CH
- Submission Type
For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.