The following data is part of a premarket notification filed by United Diagnostics, Inc. with the FDA for Calibration Standard-hemoglobin.
| Device ID | K831814 |
| 510k Number | K831814 |
| Device Name: | CALIBRATION STANDARD-HEMOGLOBIN |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| Applicant | UNITED DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRZ |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-06 |
| Decision Date | 1983-07-28 |