The following data is part of a premarket notification filed by Technopath Manufacturing with the FDA for Multichem A1c.
| Device ID | K162514 |
| 510k Number | K162514 |
| Device Name: | Multichem A1c |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Technopath Manufacturing Fort Henry Business Park Ballina, IE |
| Contact | Bernd Hass |
| Correspondent | Bernd Hass Technopath Manufacturing Fort Henry Business Park Ballina, IE |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-08 |
| Decision Date | 2016-10-26 |
| Summary: | summary |