The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Microwell Reader.
| Device ID | K841557 |
| 510k Number | K841557 |
| Device Name: | ORTHO MICROWELL 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 | 1984-04-16 |
| Decision Date | 1984-05-22 |