Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
FDA 510(k) clearance K191396 · decided 2019-07-26
Clearance details
- K-number
- K191396
- Device name
- Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
- Applicant
- HORIBA ABX SAS
- Decision
- Substantially Equivalent
- Date received
- 2019-05-24
- Decision date
- 2019-07-26
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- CJY
- Device class
- 2
- Regulation number
- 862.1145
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Montpellier Cedex 4, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.