s LDL-EX SEIKEN
FDA 510(k) clearance K161679 · decided 2017-08-18
Clearance details
- K-number
- K161679
- Device name
- s LDL-EX SEIKEN
- Applicant
- Denka Seiken Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-17
- Decision date
- 2017-08-18
- Days to decision
- 427 days
- Clearance type
- Traditional
- Product code
- PYP
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Gosen, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.