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 |