The following data is part of a premarket notification filed by Techno-path Manufacturing with the FDA for Multichem Ia Plus.
| Device ID | K162530 |
| 510k Number | K162530 |
| Device Name: | Multichem IA Plus |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | TECHNO-PATH MANUFACTURING BALLINA Co. Tipperary, IE |
| Contact | Bernd Hass |
| Correspondent | Bernd Hass TECHNO-PATH MANUFACTURING BALLINA Co. Tipperary, IE |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-09 |
| Decision Date | 2017-03-31 |
| Summary: | summary |