The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Qm300 Calibrator D Pack.
| Device ID | K883001 |
| 510k Number | K883001 |
| Device Name: | QM300 CALIBRATOR D PACK |
| Classification | Igd, Antigen, Antiserum, Control |
| Applicant | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Jan Nebelsick |
| Correspondent | Jan Nebelsick KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | CZJ |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-18 |
| Decision Date | 1988-09-22 |