FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
s LDL-EX SEIKEN
K Number: K161679
·
Decision Aug 18, 2017
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
6
Review Days
427
Basic Information
- Device Name
- s LDL-EX SEIKEN
- K Number
- K161679
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DENKA SEIKEN CO., LTD.
- Date Received
- June 17, 2016
- Decision Date
- August 18, 2017
- Product Code
- PYP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PYP | Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test | FDA class 1 | Clinical Chemistry |
Other Clearances by DENKA SEIKEN CO., LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K060359 | ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 | Apr 14, 2006 | Substantially Equivalent |
| K043264 | LDL-EX SEIKEN ASSAY KIT | Jan 26, 2005 | Substantially Equivalent |
| K041090 | HDL-EX SEIKEN ASSAY KIT | Oct 29, 2004 | Substantially Equivalent |
| K030545 | CRP-LATEX (II)X2 SEIKEN ASSAY KIT | Jun 2, 2003 | Substantially Equivalent |
| K030546 | CRP (II) CALIBRATORS | Jun 2, 2003 | Substantially Equivalent |