The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Bacteriuria Detection Sys.
| Device ID | K833834 |
| 510k Number | K833834 |
| Device Name: | ORTHO BACTERIURIA DETECTION SYS |
| Classification | Kit, Screening, Urine |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-03 |
| Decision Date | 1984-03-12 |