The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra 400, Calcium Cp, Creatinine Cp, Phosphorus Cp, Amylase Cp, Urine Control L/h.
| Device ID | K070249 |
| 510k Number | K070249 |
| Device Name: | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Contact | Pascal Macziola |
| Correspondent | Pascal Macziola HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Product Code | CIC |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CGX |
| Subsequent Product Code | JFJ |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-26 |
| Decision Date | 2007-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230006849 | K070249 | 000 |
| 03610230005194 | K070249 | 000 |
| 03610230004913 | K070249 | 000 |