The following data is part of a premarket notification filed by American Dade with the FDA for Aqueous Blood Gas Control Level I,ii &.
| Device ID | K832003 |
| 510k Number | K832003 |
| Device Name: | AQUEOUS BLOOD GAS CONTROL LEVEL I,II & |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | AMERICAN DADE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-22 |
| Decision Date | 1983-08-10 |