The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Nds Theophylline Test Kit & Nds Tdm Calibrator Set.
| Device ID | K900009 |
| 510k Number | K900009 |
| Device Name: | NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Jan Olsen |
| Correspondent | Jan Olsen KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-02 |
| Decision Date | 1990-03-29 |