The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Calcium Reagent For Astra 8 Autom Stat/rout/analyz.
| Device ID | K853050 |
| 510k Number | K853050 |
| Device Name: | CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ |
| Classification | Cresolphthalein Complexone, Calcium |
| 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 | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-19 |
| Decision Date | 1985-08-02 |