The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Albumin Reagent For Astra 8 Auto Stat/rout Analyze.
| Device ID | K853049 |
| 510k Number | K853049 |
| Device Name: | ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | SIMMLER, INC. 3755 FOREST PARK AVE. St. Louis, MO 63108 |
| Contact | R. M Boedeker |
| Correspondent | R. M Boedeker SIMMLER, INC. 3755 FOREST PARK AVE. St. Louis, MO 63108 |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-19 |
| Decision Date | 1985-08-02 |