The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Pentra C200, Ise Module And Abx Pentra Glucose Hk Cp Reagent.
| Device ID | K103788 |
| 510k Number | K103788 |
| Device Name: | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT |
| Classification | Hexokinase, Glucose |
| Applicant | HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE - BP7290 Montpellier, FR 34184 |
| Contact | Caroline Ferrer |
| Correspondent | Caroline Ferrer HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE - BP7290 Montpellier, FR 34184 |
| Product Code | CFR |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230006689 | K103788 | 000 |
| 03610230006672 | K103788 | 000 |