The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Allercoat Microplate System.
| Device ID | K900028 |
| 510k Number | K900028 |
| Device Name: | ALLERCOAT MICROPLATE SYSTEM |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Susan Tesmer |
| Correspondent | Susan Tesmer KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-03 |
| Decision Date | 1990-01-22 |