The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Trust Rpr Titration Card Test #65145.
| Device ID | K832480 |
| 510k Number | K832480 |
| Device Name: | TRUST RPR TITRATION CARD TEST #65145 |
| Classification | Antigens, Nontreponemal, All |
| Applicant | EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-26 |
| Decision Date | 1983-09-12 |