The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra Amylase Cp; Multical; N Control; P Control; Clean-chem Cp; Clean-chem 99 Cp.
| Device ID | K062180 |
| 510k Number | K062180 |
| Device Name: | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP |
| Classification | Catalytic Methods, Amylase |
| 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 | JFJ |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-31 |
| Decision Date | 2006-10-02 |
| Summary: | summary |