The following data is part of a premarket notification filed by Bio-rad with the FDA for Lyphochek Immunoassay Serum Control Level I,ii,iii.
| Device ID | K864137 |
| 510k Number | K864137 |
| Device Name: | LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | BIO-RAD 2400 WRIGHT AVE. Richmond, CA 94804 |
| Contact | Frank Matarrese |
| Correspondent | Frank Matarrese BIO-RAD 2400 WRIGHT AVE. Richmond, CA 94804 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1986-11-07 |