The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem Icon Rubella Igg Immunoenzymetric Assay Kit.
| Device ID | K853069 |
| 510k Number | K853069 |
| Device Name: | TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | John F Bruni |
| Correspondent | John F Bruni HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-22 |
| Decision Date | 1986-01-01 |