The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Elisa Rotavirus Kit- 96 Tests K440.
| Device ID | K912666 |
| 510k Number | K912666 |
| Device Name: | DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | DAKO CORP. P.O. BOX 1359 DK-2600 GLOSTRUP Denmark, DK |
| Contact | Debora D Hinman |
| Correspondent | Debora D Hinman DAKO CORP. P.O. BOX 1359 DK-2600 GLOSTRUP Denmark, DK |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-18 |
| Decision Date | 1992-02-14 |