The following data is part of a premarket notification filed by Memed Diagnostics Ltd. with the FDA for Memed Bv.
Device ID | K210254 |
510k Number | K210254 |
Device Name: | MeMed BV |
Classification | Procalcitonin Assay |
Applicant | MeMed Diagnostics Ltd. Nahum Heth 5 Tirat Carmel, IL 3508504 |
Contact | Efrat Hartog-david |
Correspondent | Efrat Hartog-david MeMed Diagnostics Ltd. Nahum Heth 5 Tirat Carmel, IL 3508504 |
Product Code | PRI |
CFR Regulation Number | 866.3215 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-01-29 |
Decision Date | 2021-09-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17290018739034 | K210254 | 000 |
17290018739027 | K210254 | 000 |
17290018739003 | K210254 | 000 |
17290018739010 | K210254 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MEMED BV 79286202 not registered Live/Pending |
MeMed Diagnostics Ltd. 2020-04-21 |