The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Manualisa Microtitration Plate Reader.
| Device ID | K823590 |
| 510k Number | K823590 |
| Device Name: | MANUALISA MICROTITRATION PLATE READER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-06 |
| Decision Date | 1983-02-28 |