The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Urine Cal.
Device ID | K071779 |
510k Number | K071779 |
Device Name: | ABX PENTRA URINE CAL |
Classification | Calibrator, Multi-analyte Mixture |
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 | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-02 |
Decision Date | 2008-03-05 |
Summary: | summary |