The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Platelia Rubella Igg Kit.
| Device ID | K894946 |
| 510k Number | K894946 |
| Device Name: | PLATELIA RUBELLA IGG KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Susan Tesmer |
| Correspondent | Susan Tesmer KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-03 |
| Decision Date | 1989-12-21 |