The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Glucose Hk Cp, Urea Cp, Uric Acid Cp.
| Device ID | K070146 |
| 510k Number | K070146 |
| Device Name: | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier, FR 34184 |
| Contact | Pascal Macziola |
| Correspondent | Pascal Macziola HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier, FR 34184 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-10-12 |
| Summary: | summary |