510(k) K161679
- Device
- S LDL-EX SEIKEN
- Applicant
- DENKA SEIKEN CO., LTD.
- 510(k) number
- K161679
- Product code
- PYP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-08-18
- Date received
- 2016-06-17
- Regulation
- 862.1475
- Classification name
- Low-density Lipoprotein (ldl) Cholesterol Sub-fraction Test
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Takayoshi Ishii
- Address
- 1359-I, Kagamida, Kigoshi Gosen JP 959-1695 959-1695
FDA Registration Numbers#
- 3003871639
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary