The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Calibrating Solution For Abl-1 & 2.
| Device ID | K831021 |
| 510k Number | K831021 |
| Device Name: | CALIBRATING SOLUTION FOR ABL-1 & 2 |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | FISHER SCIENTIFIC CO., LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-30 |
| Decision Date | 1983-06-16 |