The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Carbon Dioxide Cup Reagent & Ref.rgt..
| Device ID | K800218 |
| 510k Number | K800218 |
| Device Name: | CARBON DIOXIDE CUP REAGENT & REF.RGT. |
| Classification | Ph Rate Measurement, Carbon-dioxide |
| Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JFL |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-04 |
| Decision Date | 1980-02-26 |