The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Kallestad Qm300 Protein Analysis System.
| Device ID | K871339 |
| 510k Number | K871339 |
| Device Name: | KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM |
| Classification | Calculator/data Processing Module, For Clinical Use |
| Applicant | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Jan Petersen |
| Correspondent | Jan Petersen KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | JQP |
| CFR Regulation Number | 862.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-02 |
| Decision Date | 1987-05-15 |