The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem (r) Total Bilirubin.
| Device ID | K874311 |
| 510k Number | K874311 |
| Device Name: | MULTICHEM (R) TOTAL BILIRUBIN |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Contact | Quincy E Crider |
| Correspondent | Quincy E Crider SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-20 |
| Decision Date | 1987-11-25 |