The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Bilirubin, Direct Cp, Abx Pentra Bilirubin, Total Cp, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P.
| Device ID | K060325 |
| 510k Number | K060325 |
| Device Name: | ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Contact | Tim Lawton |
| Correspondent | Tim Lawton HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE Montpellier, Herault, FR 34184 |
| Product Code | CIG |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-09 |
| Decision Date | 2006-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230006887 | K060325 | 000 |
| 03610230006870 | K060325 | 000 |
| 03610230005026 | K060325 | 000 |
| 03610230004982 | K060325 | 000 |