The following data is part of a premarket notification filed by Interscience, Inc. with the FDA for Calibrator For Hemoglobin & Hemocrit.
| Device ID | K822327 |
| 510k Number | K822327 |
| Device Name: | CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| Applicant | INTERSCIENCE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRZ |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-03 |
| Decision Date | 1982-11-16 |