The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Qualicheck 4.
| Device ID | K915399 |
| 510k Number | K915399 |
| Device Name: | QUALICHECK 4 |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Donald Baker |
| Correspondent | Donald Baker RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-01-02 |