The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Kallestad Rsv Microplate Eia.
| Device ID | K924289 |
| 510k Number | K924289 |
| Device Name: | KALLESTAD RSV MICROPLATE EIA |
| Classification | Respiratory Syncytial Virus - Elisa |
| 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 | MCE |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-21 |
| Decision Date | 1993-02-12 |