The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Rotacube.
| Device ID | K884017 |
| 510k Number | K884017 |
| Device Name: | ROTACUBE |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | Robert |
| Correspondent | Robert DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-22 |
| Decision Date | 1989-01-24 |