The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Bi-level Receptor Control.
| Device ID | K834064 |
| 510k Number | K834064 |
| Device Name: | ORTHO BI-LEVEL RECEPTOR CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-25 |
| Decision Date | 1984-03-23 |