The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad Sm/rnp Test Reagent.
Device ID | K862313 |
510k Number | K862313 |
Device Name: | KALLESTAD SM/RNP TEST REAGENT |
Classification | Antinuclear Antibody, Antigen, Control |
Applicant | KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
Contact | Katia Breslawec |
Correspondent | Katia Breslawec KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
Product Code | LKJ |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-18 |
Decision Date | 1986-08-06 |