The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 2000 Anti-ccp Igg Assay.
| Device ID | K121576 |
| 510k Number | K121576 |
| Device Name: | IMMULITE 2000 ANTI-CCP IGG ASSAY |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Susan Brocchi |
| Correspondent | Susan Brocchi Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | NHX |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-30 |
| Decision Date | 2013-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414601991 | K121576 | 000 |
| 00630414000206 | K121576 | 000 |