The following data is part of a premarket notification filed by Interscience Diagnostics, Inc. with the FDA for Hematology Calibrator Control.
| Device ID | K854166 |
| 510k Number | K854166 |
| Device Name: | HEMATOLOGY CALIBRATOR CONTROL |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| Applicant | INTERSCIENCE DIAGNOSTICS, INC. P.O. BOX 897 Fairview, OR 97024 |
| Contact | William Whelpley |
| Correspondent | William Whelpley INTERSCIENCE DIAGNOSTICS, INC. P.O. BOX 897 Fairview, OR 97024 |
| Product Code | KRZ |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-15 |
| Decision Date | 1986-03-12 |