MULTIGENT CREATININE (ENZYMATIC) ASSAY
FDA 510(k) clearance K073634 · decided 2008-06-19
Clearance details
- K-number
- K073634
- Device name
- MULTIGENT CREATININE (ENZYMATIC) ASSAY
- Applicant
- SENTINEL CH. SpA
- Decision
- Substantially Equivalent
- Date received
- 2007-12-26
- Decision date
- 2008-06-19
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- JFY
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Milan, IT
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch SENTINEL CH. SpA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for t recall (Z-2867-2017) | Sentinel CH SPA | 2017-06-27 |