The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Platelia Rubella Igg Kit.
Device ID | K894946 |
510k Number | K894946 |
Device Name: | PLATELIA RUBELLA IGG KIT |
Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
Applicant | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
Contact | Susan Tesmer |
Correspondent | Susan Tesmer KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
Product Code | LFX |
CFR Regulation Number | 866.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-03 |
Decision Date | 1989-12-21 |