The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Tri-level Tdm Control & I Ii Iii.
| Device ID | K831500 |
| 510k Number | K831500 |
| Device Name: | TRI-LEVEL TDM CONTROL & I II III |
| Classification | Drug Mixture Control Materials |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-11 |
| Decision Date | 1983-06-30 |