The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Kallestad Rotavirus Microplate.
| Device ID | K915137 |
| 510k Number | K915137 |
| Device Name: | KALLESTAD ROTAVIRUS MICROPLATE |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Cheri W.fink |
| Correspondent | Cheri W.fink BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1992-03-04 |