s LDL-EX SEIKEN
FDA 510(k) K161679 · Denka Seiken Co., Ltd.
510(k) numberK161679
Submission
- Device name
- s LDL-EX SEIKEN
- Applicant
- Denka Seiken Co., Ltd.
Gosen, JP - Received
- June 17, 2016
- Decision date
- August 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PYP – Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
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|---|---|---|
| K060359 | Archiect Insulin and Controls, Model 8K41-01, 8K41-10JIT · Abbreviated | 04/14/2006SE |
| K043264 | Ldl-Ex Seiken Assay KitMRR · Traditional | 01/26/2005SE |
| K041090 | Hdl-Ex Seiken Assay KitLBS · Traditional | 10/29/2004SE |
| K030546 | CRP (II) CalibratorsJIS · Traditional | 06/02/2003SE |
| K030545 | Crp-Latex (II)X2 Seiken Assay KitDCK · Traditional | 06/02/2003SE |
Questions and answers
When was s LDL-EX SEIKEN cleared by the FDA?
s LDL-EX SEIKEN (K161679) received a 510(k) decision of Substantially Equivalent on August 18, 2017, 427 days after the submission was received.
What is the product code of K161679?
The FDA product code is PYP – Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test, a Class I (low risk) device regulated under 21 CFR 862.1475.