The following data is part of a premarket notification filed by Medical Electronics Systems Ltd. with the FDA for Qwikcheck-beads.
| Device ID | K041600 |
| 510k Number | K041600 |
| Device Name: | QWIKCHECK-BEADS |
| Classification | Material, Quality Control, Semen Analysis |
| Applicant | MEDICAL ELECTRONICS SYSTEMS LTD. 575 Shirlynn Court Los Altos, CA 94022 |
| Contact | Erika B Ammirati |
| Correspondent | Erika B Ammirati MEDICAL ELECTRONICS SYSTEMS LTD. 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | NRF |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016650020 | K041600 | 000 |
| 07290012140600 | K041600 | 000 |
| 07290012140136 | K041600 | 000 |