The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Klinar Reagent Pak, #36010.
| Device ID | K801892 |
| 510k Number | K801892 |
| Device Name: | KLINAR REAGENT PAK, #36010 |
| Classification | Flame Photometry, Sodium |
| Applicant | HI CHEM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JGT |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-08 |
| Decision Date | 1980-10-23 |