The following data is part of a premarket notification filed by New Horizons Diagnostics Co. with the FDA for Rapid Bacteriuria Screen (rbs).
| Device ID | K862195 |
| 510k Number | K862195 |
| Device Name: | RAPID BACTERIURIA SCREEN (RBS) |
| Classification | Kit, Screening, Urine |
| Applicant | NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Contact | David Trudil |
| Correspondent | David Trudil NEW HORIZONS DIAGNOSTICS CO. 9110 RED BRANCH RD. SUITE B Columbia, MD 21045 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-09 |
| Decision Date | 1986-06-30 |