The following data is part of a premarket notification filed by Techno-path Manufacturing Ltd. with the FDA for Multichem Ia And Ia Plus.
| Device ID | K132091 |
| 510k Number | K132091 |
| Device Name: | MULTICHEM IA AND IA PLUS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | TECHNO-PATH MANUFACTURING LTD. 325 BIG ELM ST. Highland Village, TX 75077 |
| Contact | Stephanie G Garth |
| Correspondent | Stephanie G Garth TECHNO-PATH MANUFACTURING LTD. 325 BIG ELM ST. Highland Village, TX 75077 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-08 |
| Decision Date | 2013-09-20 |
| Summary: | summary |