The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Kalestad Ana Microplate Eia.
| Device ID | K924087 |
| 510k Number | K924087 |
| Device Name: | KALESTAD ANA MICROPLATE EIA |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Laurel Hoover |
| Correspondent | Laurel Hoover BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-13 |
| Decision Date | 1992-11-02 |