The following data is part of a premarket notification filed by Medical Electronic Systems Ltd. with the FDA for Qwikcheck Test Strips- Reagent Strips For Semen Analysis.
| Device ID | K063864 |
| 510k Number | K063864 |
| Device Name: | QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS |
| Classification | Semen Analysis Device |
| Applicant | MEDICAL ELECTRONIC SYSTEMS LTD. 575 SHIRLYNN CT. Los Altos, CA 94022 |
| Contact | Erika B Ammirati |
| Correspondent | Erika B Ammirati MEDICAL ELECTRONIC SYSTEMS LTD. 575 SHIRLYNN CT. Los Altos, CA 94022 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-29 |
| Decision Date | 2007-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290012140167 | K063864 | 000 |