The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Glucose Hk Cp, Abx Pentra Uric Acid Cp, Abx Pentra Urine Control L/h.
| Device ID | K081276 |
| 510k Number | K081276 |
| Device Name: | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H |
| Classification | Hexokinase, Glucose |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier, FR 34184 |
| Contact | Olivier Ducamp |
| Correspondent | Olivier Ducamp HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 Montpellier, FR 34184 |
| Product Code | CFR |
| Subsequent Product Code | JJY |
| Subsequent Product Code | KNK |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-05 |
| Decision Date | 2008-09-12 |
| Summary: | summary |