The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Txocell-iha Reagent System.
| Device ID | K790460 |
| 510k Number | K790460 |
| Device Name: | TXOCELL-IHA REAGENT SYSTEM |
| Classification | Antigens, Iha, Toxoplasma Gondii |
| Applicant | CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMM |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-03-05 |
| Decision Date | 1979-05-25 |