The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Qm300 Calibrator A Pack.
Device ID | K871341 |
510k Number | K871341 |
Device Name: | QM300 CALIBRATOR A PACK |
Classification | Calibrator, Multi-analyte Mixture |
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 | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-02 |
Decision Date | 1987-05-21 |