The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Qm300 Rheumatoid Factor Antigen Pack.
Device ID | K883536 |
510k Number | K883536 |
Device Name: | QM300 RHEUMATOID FACTOR ANTIGEN PACK |
Classification | System, Test, Rheumatoid Factor |
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 | DHR |
CFR Regulation Number | 866.5775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-18 |
Decision Date | 1988-09-07 |