The following data is part of a premarket notification filed by Labsystems, Inc. with the FDA for Rubella Igm Eia Test Kit.
| Device ID | K862431 |
| 510k Number | K862431 |
| Device Name: | RUBELLA IGM EIA TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | LABSYSTEMS, INC. 6200 W. OAKTON Morton Grove, IL 60053 |
| Contact | Paivi Sormunen |
| Correspondent | Paivi Sormunen LABSYSTEMS, INC. 6200 W. OAKTON Morton Grove, IL 60053 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-26 |
| Decision Date | 1986-08-08 |