The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Trust Rpr Card Test #65144.
Device ID | K832479 |
510k Number | K832479 |
Device Name: | TRUST RPR CARD TEST #65144 |
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 |