The following data is part of a premarket notification filed by Dako Diagnostics Ltd. with the FDA for Ideia(tm) Chlamydia Blocking Reagents, Modification.
| Device ID | K940564 |
| 510k Number | K940564 |
| Device Name: | IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION |
| Classification | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Applicant | DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire, GB Cb7 4et |
| Contact | Elisabeth A Johnson-proctor |
| Correspondent | Elisabeth A Johnson-proctor DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire, GB Cb7 4et |
| Product Code | LJC |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-03 |
| Decision Date | 1996-01-11 |