The following data is part of a premarket notification filed by Macomb Chemical Co. with the FDA for Rapid Chem Analyzer Ii.
| Device ID | K830095 |
| 510k Number | K830095 |
| Device Name: | RAPID CHEM ANALYZER II |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | MACOMB CHEMICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-11 |
| Decision Date | 1983-01-28 |