The following data is part of a premarket notification filed by Combact Diagnostic Systems Ltd. with the FDA for Urine Screening Device.
| Device ID | K972676 |
| 510k Number | K972676 |
| Device Name: | URINE SCREENING DEVICE |
| Classification | Kit, Screening, Urine |
| Applicant | COMBACT DIAGNOSTIC SYSTEMS LTD. 16809 BRIARDALE RD. Rockville, MD 20855 |
| Contact | Thomas M Tsakeris |
| Correspondent | Thomas M Tsakeris COMBACT DIAGNOSTIC SYSTEMS LTD. 16809 BRIARDALE RD. Rockville, MD 20855 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-16 |
| Decision Date | 1998-02-23 |
| Summary: | summary |