The following data is part of a premarket notification filed by American Dade with the FDA for Paramax Chloride Reagent.
| Device ID | K841047 |
| 510k Number | K841047 |
| Device Name: | PARAMAX CHLORIDE REAGENT |
| Classification | Mercuric Thiocyanate, Colorimetry, Chloride |
| Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHJ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-12 |
| Decision Date | 1984-04-19 |