The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem Creatinine Reagent S0917.
| Device ID | K873725 |
| 510k Number | K873725 |
| Device Name: | MULTICHEM CREATININE REAGENT S0917 |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Contact | Quincy E Crider,phd |
| Correspondent | Quincy E Crider,phd SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-15 |
| Decision Date | 1987-10-20 |