The following data is part of a premarket notification filed by American Dade with the FDA for Dade Blood Gas Ampul Injector.
| Device ID | K852285 |
| 510k Number | K852285 |
| Device Name: | DADE BLOOD GAS AMPUL INJECTOR |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | James E Keller |
| Correspondent | James E Keller AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-07-09 |