ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
FDA 510(k) clearance K110137 · decided 2011-08-10
Clearance details
- K-number
- K110137
- Device name
- ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
- Applicant
- HORIBA ABX SAS
- Decision
- Substantially Equivalent
- Date received
- 2011-01-18
- Decision date
- 2011-08-10
- Days to decision
- 204 days
- Clearance type
- Abbreviated
- Product code
- JFY
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Montpellier, FR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch HORIBA ABX SAS
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 |
|---|---|---|
| ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative recall (Z-0739-2016) | Horiba Instruments Inc | 2016-02-02 |
| ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and Hig recall (Z-0924-2014) | Horiba Instruments, Inc dba Horiba Medical | 2014-02-03 |