The following data is part of a premarket notification filed by Medicor Usa Ltd. with the FDA for Medicor Quality Control Buffer.
| Device ID | K791287 |
| 510k Number | K791287 |
| Device Name: | MEDICOR QUALITY CONTROL BUFFER |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | MEDICOR USA LTD. 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 | 1979-07-10 |
| Decision Date | 1979-08-16 |