The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Total Protein Reagent For Astra 8 Stat/rou Analyze.
| Device ID | K853244 |
| 510k Number | K853244 |
| Device Name: | TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | SIMMLER, INC. 3755 FOREST PARK AVE. St. Louis, MO 63108 |
| Contact | Boedeker |
| Correspondent | Boedeker SIMMLER, INC. 3755 FOREST PARK AVE. St. Louis, MO 63108 |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-01 |
| Decision Date | 1985-08-12 |