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 |