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 |