The following data is part of a premarket notification filed by Health Diagnostics Corp. with the FDA for Blood Gas Control Prod. No. Bg-1, Bg-2.
| Device ID | K801449 |
| 510k Number | K801449 |
| Device Name: | BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | HEALTH DIAGNOSTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-23 |
| Decision Date | 1980-07-21 |