The following data is part of a premarket notification filed by Horiba Abx with the FDA for Abx Pentra 400 : Crp.
| Device ID | K061138 |
| 510k Number | K061138 |
| Device Name: | ABX PENTRA 400 : CRP |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| 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 | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-24 |
| Decision Date | 2006-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610230005477 | K061138 | 000 |
| 03610230004821 | K061138 | 000 |
| 03610230004791 | K061138 | 000 |