The following data is part of a premarket notification filed by Dakocytomation Ltd with the FDA for Ideia Pce Chlamydia.
| Device ID | K033865 |
| 510k Number | K033865 |
| Device Name: | IDEIA PCE CHLAMYDIA |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | DAKOCYTOMATION LTD DENMARK HOUSE, ANGEL DROVE Ely, Cambridgeshire, GB Cb7 4et |
| Contact | Jennie Oates |
| Correspondent | Jennie Oates DAKOCYTOMATION LTD DENMARK HOUSE, ANGEL DROVE Ely, Cambridgeshire, GB Cb7 4et |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-12 |
| Decision Date | 2004-01-21 |