CCPOINT
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
EURO-DIAGNOSTICA AB
The following data is part of a premarket notification filed by Euro-diagnostica Ab with the FDA for Ccpoint.
Pre-market Notification Details
| Device ID | K093908 |
| 510k Number | K093908 |
| Device Name: | CCPOINT |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | EURO-DIAGNOSTICA AB 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff EURO-DIAGNOSTICA AB 1129 BLOOMFIELD AVENUE West Caldwell, NJ 07006 |
| Product Code | NHX |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-12-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07340058410431 | K093908 | 000 |
Trademark Results [CCPOINT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CCPOINT 77076758 3380330 Dead/Cancelled |
Euro-Diagnostica AB 2007-01-05 |
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