The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Kallestead Total Ige Microplate Kit.
| Device ID | K912800 |
| 510k Number | K912800 |
| Device Name: | KALLESTEAD TOTAL IGE MICROPLATE KIT |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Nebelsick Theisen |
| Correspondent | Nebelsick Theisen BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-25 |
| Decision Date | 1991-07-25 |