The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Autogrouper 16c Sys Automated Reag.
| Device ID | K834149 |
| 510k Number | K834149 |
| Device Name: | AUTOGROUPER 16C SYS AUTOMATED REAG |
| Classification | Antigens, Nontreponemal, All |
| Applicant | TECHNICON INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-01 |
| Decision Date | 1984-03-09 |