The following data is part of a premarket notification filed by Oxarc, Inc. with the FDA for Clinical Blood Gas Mixtures.
| Device ID | K964475 |
| 510k Number | K964475 |
| Device Name: | CLINICAL BLOOD GAS MIXTURES |
| Classification | Calibrator, Primary |
| Applicant | OXARC, INC. 716 SOUTH OREGON AVE. Pasco, WA 99301 |
| Contact | Travis Auger |
| Correspondent | Travis Auger OXARC, INC. 716 SOUTH OREGON AVE. Pasco, WA 99301 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-07 |
| Decision Date | 1996-12-06 |