The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Enzyme-immunoassay (rubella Antibodies).
| Device ID | K801098 |
| 510k Number | K801098 |
| Device Name: | ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) |
| Classification | Antigen, Ha (including Ha Control), Rubella |
| Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GOL |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-09 |
| Decision Date | 1980-09-16 |