The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Modified Pathfinder Specimen Collection Kit.
Device ID | K870963 |
510k Number | K870963 |
Device Name: | MODIFIED PATHFINDER SPECIMEN COLLECTION KIT |
Classification | Device, Specimen Collection |
Applicant | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
Contact | Quinlan Smith |
Correspondent | Quinlan Smith KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
Product Code | LIO |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-10 |
Decision Date | 1987-04-08 |