The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Qm300 Antistreptolysin O (aso) Antigen Pack.
Device ID | K910886 |
510k Number | K910886 |
Device Name: | QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK |
Classification | Antistreptolysin - Titer/streptolysin O Reagent |
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 | GTQ |
CFR Regulation Number | 866.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-04 |
Decision Date | 1991-06-17 |