The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Multichem Hdl Precipitating Reagent #s0914.
| Device ID | K874820 |
| 510k Number | K874820 |
| Device Name: | MULTICHEM HDL PRECIPITATING REAGENT #S0914 |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Contact | Crider, Phd |
| Correspondent | Crider, Phd SIMMLER, INC. POST OFFICE BOX 25179 St. Louis, MO 63125 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-24 |
| Decision Date | 1988-01-07 |