The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Rubella-cube(tm).
| Device ID | K892051 |
| 510k Number | K892051 |
| Device Name: | RUBELLA-CUBE(TM) |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | M. T Robert |
| Correspondent | M. T Robert DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-29 |
| Decision Date | 1989-06-08 |