The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Mago Automated Eia Processor.
| Device ID | K973177 |
| 510k Number | K973177 |
| Device Name: | MAGO AUTOMATED EIA PROCESSOR |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Lynne Stirling |
| Correspondent | Lynne Stirling DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-25 |
| Decision Date | 1997-10-09 |
| Summary: | summary |