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 |