The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Technicon Chem 1(r)/chem 1+(tm) Software Ver 11.1.
| Device ID | K925203 |
| 510k Number | K925203 |
| Device Name: | TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Robert L Habig |
| Correspondent | Robert L Habig HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1992-11-25 |