URISCREEN
Kit, Screening, Urine
DIATECH DIAGNOSTICA LTD.
The following data is part of a premarket notification filed by Diatech Diagnostica Ltd. with the FDA for Uriscreen.
Pre-market Notification Details
| Device ID | K882211 |
| 510k Number | K882211 |
| Device Name: | URISCREEN |
| Classification | Kit, Screening, Urine |
| Applicant | DIATECH DIAGNOSTICA LTD. C/O MACKLER, COOPER & GIBBS PC 1120 VERMONT AVE, NW, STE 600 Washington, DC 20005 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler DIATECH DIAGNOSTICA LTD. C/O MACKLER, COOPER & GIBBS PC 1120 VERMONT AVE, NW, STE 600 Washington, DC 20005 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-26 |
| Decision Date | 1988-09-30 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10763924601568 | K882211 | 000 |
Trademark Results [URISCREEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 URISCREEN 75749174 2395410 Live/Registered |
Savyon Diagnostics Ltd. 1999-07-13 |
 URISCREEN 73803723 1673177 Dead/Cancelled |
DIATECH INC. 1989-06-01 |
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