The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Calcium Dye Reagent-cs-718-a/buffer.
| Device ID | K833035 |
| 510k Number | K833035 |
| Device Name: | CALCIUM DYE REAGENT-CS-718-A/BUFFER |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-07 |
| Decision Date | 1983-11-03 |