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 |