The following data is part of a premarket notification filed by Bioscreen Inc. with the FDA for Qc-beads.
Device ID | K042750 |
510k Number | K042750 |
Device Name: | QC-BEADS |
Classification | Material, Quality Control, Semen Analysis |
Applicant | BIOSCREEN INC. 889 BROADWAY - SUITE 6A New York, NY 10003 |
Contact | Alice Deutsch |
Correspondent | Alice Deutsch BIOSCREEN INC. 889 BROADWAY - SUITE 6A New York, NY 10003 |
Product Code | NRF |
CFR Regulation Number | 864.8625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-04 |
Decision Date | 2004-10-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QC-BEADS 87382599 5356851 Live/Registered |
Bioscreen, Inc. 2017-03-23 |