The following data is part of a premarket notification filed by Dako Diagnostics Ltd. with the FDA for Ideia(tm) Rotavirus.
| Device ID | K932384 |
| 510k Number | K932384 |
| Device Name: | IDEIA(TM) ROTAVIRUS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire, GB Cb7 4et |
| Contact | Johnson-proctor |
| Correspondent | Johnson-proctor DAKO DIAGNOSTICS LTD. DENMARK HOUSE, ANGEL DROVE, ELY Cambridgeshire, GB Cb7 4et |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-17 |
| Decision Date | 1993-12-27 |